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open or by gently pressing on the columella.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $874.9. (64 FR 10949, Mar. 8, 1999)

The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996)

8874.3930 Tympanostomy tube with

semipermeable membrane. (a) Identification. A tympanostomy tube with a semipermeable membrane is a device intended to be implanted for ventilation or drainage of the middle ear and for preventing fluids from entering the middle ear cavity. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. The tube portion of the device is made of silicone elastomer or porous polyethylene, and the membrane portion is made of polytetrafluoroethylene.

(b) Classification. Class II. The special control for this device is FDA's "Tympanostomy Tubes, Submission Guidance for a 510(k).” (51 FR 40389, Nov. 6, 1986, as amended at 65 FR 17145, Mar. 31, 2000)

8874.4175 Nasopharyngeal catheter.

(a) Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996)

Subpart E-Surgical Devices

$ 874.4250 Ear, nose, and throat elec

tric or pneumatic surgical drill. (a) Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur ($ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

(b) Classification. Class II.

8874.4100 Epistaxis balloon.

(a) Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

(b) Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $874.9. (51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000)

8874.4140 Ear, nose, and throat bur.

(a) Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (874.4250) for incising or removing bone in the ear, nose, or throat area.

8874.4350 Ear, nose,

and throat fiberoptic light source and carrier. (a) Identification. An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial

telescope, and nasopharyngoscope.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996)

used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In rhinology and laryngology, the device is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.

(b) Classification. Class II.

[58 FR 29534, May 21, 1993)

$ 874.4500 Ear, nose, and throat micro

surgical carbon dioxide laser. (a) Identification. An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.

(b) Classification. Class II.

or

$ 874.4420 Ear, nose, and throat man

ual surgical instrument. (a) Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tub; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tub; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

(b) Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $874.9. (51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000)

8 874.4680 Bronchoscope (flexible

rigid) and accessories. (a) Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

(b) Classification. Class II.

$ 874.4490 Argon laser for otology, rhi.

nology, and laryngology. (a) Identification. The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is

$874.4710 Esophagoscope (flexible or

rigid) and accessories. (a) Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or 8874.4760 Nasopharyngoscope (flexi.

ble or rigid) and accessories. (a) Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

(b) Classification. Class II.

mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

(b) Classification. Class II. $874.4720 Mediastinoscope and acces

sories. (a) Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

(b) Classification. Class II. 8874.4750 Laryngostroboscope.

(a) Identification. A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]

$874.4770 Otoscope.

(a) Identification. An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter only when used in the external ear canal.

(55 FR 48440, Nov. 20, 1990, as amended at 61 FR 1122, Jan. 16, 1996]]

$ 874.4780 Intranasal splint.

(a) Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 8 874.9. [64 FR 10949, Mar. 8, 1999)

subpart E of part 807 of this chapter subject to $874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000)

$874.4800 Bone particle collector.

(a) Identification. A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in $874.9. (64 FR 10949, Mar. 8, 1999)

Subpart F-Therapeutic Devices

8874.5220 Ear, nose, and throat drug

administration device. (a) Identification. An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice regulations in part 820 of this chapter, with the exception of $ 820.180, with respect to general requirements concerning records, and $ 820.198, with respect to complaint files.

$874.5350 Suction antichoke device.

(a) Identification. A suction antichoke device is a device intended to be used in an emergency situation to remove, by the application of suction, foreign objects that obstruct a patient's airway to prevent asphyxiation to the patient.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any suction antichoke device that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a suction antichoke device that was in commercial distribution before May 28, 1976. Any other suction antichoke device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. (51 FR 40389, Nov, 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999; 65 FR 2316, Jan. 14, 2000]

(51 FR 40389, Nov. 6, 1986, as amended at 59 FR 63009, Dec. 7, 1994)

$ 874.5300 Ear, nose, and throat exam

ination and treatment unit. (a) Identification. An ear, nose, and throat examination and treatment unit is an AC-powered device intended to support a patient during an otologic examination while providing specialized features for examination and treatment. The unit consists of a patient chair and table, drawers for equipment, suction and blowing apparatus, and receptacles for connection of specialized lights and examining instruments.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in

8874.5370 Tongs antichoke device.

(a) Identification. A tongs antichoke device is a device that is intended to be used in an emergency situation to grasp and remove foreign objects that obstruct a patient's airway to prevent asphyxiation of the patient. This generic type of device includes a plastic instrument with serrated ends that is inserted into the airway in a blind manner to grasp and extract foreign objects, and a stainless steel forceps with spoon ends that is inserted under tactile guidance to grasp and extract foreign objects from the airway.

(b) Classification. Class III.

(c) Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP for a device is required to be filed with the Food and Drug Administration on or before July 13, 1999 for any tongs antichoke device that was in commercial distribution PART 876—GASTROENTEROLOGY.

194-069 D-01--12

UROLOGY DEVICES

Subpart A-General Provisions

before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to a tongs antichoke device that was in commercial distribution before May 28, 1976. Any other tongs antichoke device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution. (51 FR 40389, Nov. 6, 1986, as amended at 64 FR 18329, Apr. 14, 1999)

Sec. 876.1 Scope. 876.3 Effective dates of requirement for pre

market approval. 876.9 Limitations of exemptions from sec

tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

8 874.5550 Powered nasal irrigator.

(a) Identification. A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $874.9. (55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2316, Jan. 14, 2000)

Subpart B-Diagnostic Devices 876.1075 Gastroenterology-urology biopsy

instrument. 876.1400 Stomach pH electrode. 876.1500 Endoscope and accessories. 876.1620 Urodynamics measurement system. 876.1725 Gastrointestinal motility moni

toring system. 876.1735 Electrogastrography system. 876.1800 Urine flow or volume measuring

system.

Subpart C-Monitoring Devices 876.2040 Enuresis alarm.

Subpart D—Prosthetic Devices 876.3350 Penile inflatable implant. 876.3630 Penile rigidity implant. 876.3750 Testicular prosthesis.

8874.5800 External nasal splint.

(a) Identification. An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

(b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. (51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, 1994]

$ 874.5840 Antistammering device.

(a) Identification. An antistammering device is a device that electronically generates a noise when activated or when it senses the user's speech and that is intended to prevent the user from hearing the sounds of his or her own voice. The device is used to minimize a user's involuntary hesitative or repetitive speech.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to $ 874.9. (51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000)

Subpart E-Surgical Devices 876.4020 Fiberoptic light ureteral catheter. 876.4270 Colostomy rod. 876.4300 Endoscopic electrosurgical unit and

accessories. 876.4370 Gastroenterology-urology

evacuator. 876.4400 Hemorrhoidal ligator. 876.4480 Electrohydraulic lithotriptor. 876.4500 Mechanical lithotriptor. 876.4530 Gastroenterology-urology

fiberoptic retractor. 876.4560 Ribdam. 876.4590 Interlocking urethral sound. 876.4620 Ureteral stent. 876.4650 Water jet renal stone dislodger sys

tem. 876.4680 Ureteral stone dislodger. 876.4730 Manual gastroenterology-urology

surgical instrument and accessories. 876.4770 Urethrotome. 876.4890 Urological table and accessories.

Subpart F-Therapeutic Devices 876.5010 Biliary catheter and accessories. 876.5030 Continent ileostomy catheter. 876.5090 Suprapubic urological catheter and

accessories. 876.5130 Urological catheter and accessories.

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