Title 21

PART 874

Part 874 - Ear, Nose, And Throat Devices

PART 874 - EAR, NOSE, AND THROAT DEVICES Authority:21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Source:51 FR 40389, Nov. 6, 1986, unless otherwise noted. Editorial Note:Nomenclature changes to part 874 appear at 73 FR 35341, June 23, 2008.

21:8.0.1.1.24.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.24.1.1.1SECTION 874.1
   874.1 Scope.
21:8.0.1.1.24.1.1.2SECTION 874.3
   874.3 Effective dates of requirement for premarket approval.
21:8.0.1.1.24.1.1.3SECTION 874.9
   874.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
21:8.0.1.1.24.2SUBPART B
Subpart B - Diagnostic Devices
21:8.0.1.1.24.2.1.1SECTION 874.1050
   874.1050 Audiometer.
21:8.0.1.1.24.2.1.2SECTION 874.1060
   874.1060 Acoustic chamber for audiometric testing.
21:8.0.1.1.24.2.1.3SECTION 874.1070
   874.1070 Short increment sensitivity index (SISI) adapter.
21:8.0.1.1.24.2.1.4SECTION 874.1080
   874.1080 Audiometer calibration set.
21:8.0.1.1.24.2.1.5SECTION 874.1090
   874.1090 Auditory impedance tester.
21:8.0.1.1.24.2.1.6SECTION 874.1100
   874.1100 Earphone cushion for audiometric testing.
21:8.0.1.1.24.2.1.7SECTION 874.1120
   874.1120 Electronic noise generator for audiometric testing.
21:8.0.1.1.24.2.1.8SECTION 874.1325
   874.1325 Electroglottograph.
21:8.0.1.1.24.2.1.9SECTION 874.1500
   874.1500 Gustometer.
21:8.0.1.1.24.2.1.10SECTION 874.1600
   874.1600 Olfactory test device.
21:8.0.1.1.24.2.1.11SECTION 874.1800
   874.1800 Air or water caloric stimulator.
21:8.0.1.1.24.2.1.12SECTION 874.1820
   874.1820 Surgical nerve stimulator/locator.
21:8.0.1.1.24.2.1.13SECTION 874.1925
   874.1925 Toynbee diagnostic tube.
21:8.0.1.1.24.3SUBPART C
Subpart C [Reserved]
21:8.0.1.1.24.4SUBPART D
Subpart D - Prosthetic Devices
21:8.0.1.1.24.4.1.1SECTION 874.3300
   874.3300 Hearing Aid.
21:8.0.1.1.24.4.1.2SECTION 874.3305
   874.3305 Wireless air-conduction hearing aid.
21:8.0.1.1.24.4.1.3SECTION 874.3310
   874.3310 Hearing aid calibrator and analysis system.
21:8.0.1.1.24.4.1.4SECTION 874.3315
   874.3315 Tympanic membrane contact hearing aid.
21:8.0.1.1.24.4.1.5SECTION 874.3320
   874.3320 Group hearing aid or group auditory trainer.
21:8.0.1.1.24.4.1.6SECTION 874.3325
   874.3325 Self-fitting air-conduction hearing aid.
21:8.0.1.1.24.4.1.7SECTION 874.3330
   874.3330 Master hearing aid.
21:8.0.1.1.24.4.1.8SECTION 874.3340
   874.3340 Active implantable bone conduction hearing system.
21:8.0.1.1.24.4.1.9SECTION 874.3375
   874.3375 Battery-powered artificial larynx.
21:8.0.1.1.24.4.1.10SECTION 874.3400
   874.3400 Tinnitus masker.
21:8.0.1.1.24.4.1.11SECTION 874.3430
   874.3430 Middle ear mold.
21:8.0.1.1.24.4.1.12SECTION 874.3450
   874.3450 Partial ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.13SECTION 874.3495
   874.3495 Total ossicular replacement prosthesis.
21:8.0.1.1.24.4.1.14SECTION 874.3540
   874.3540 Prosthesis modification instrument for ossicular replacement surgery.
21:8.0.1.1.24.4.1.15SECTION 874.3620
   874.3620 Ear, nose, and throat synthetic polymer material.
21:8.0.1.1.24.4.1.16SECTION 874.3695
   874.3695 Mandibular implant facial prosthesis.
21:8.0.1.1.24.4.1.17SECTION 874.3730
   874.3730 Laryngeal prosthesis (Taub design).
21:8.0.1.1.24.4.1.18SECTION 874.3760
   874.3760 Sacculotomy tack (Cody tack)
21:8.0.1.1.24.4.1.19SECTION 874.3820
   874.3820 Endolymphatic shunt.
21:8.0.1.1.24.4.1.20SECTION 874.3850
   874.3850 Endolymphatic shunt tube with valve.
21:8.0.1.1.24.4.1.21SECTION 874.3880
   874.3880 Tympanostomy tube.
21:8.0.1.1.24.4.1.22SECTION 874.3900
   874.3900 Nasal dilator.
21:8.0.1.1.24.4.1.23SECTION 874.3930
   874.3930 Tympanostomy tube with semipermeable membrane.
21:8.0.1.1.24.4.1.24SECTION 874.3950
   874.3950 Transcutaneous air conduction hearing aid system.
21:8.0.1.1.24.5SUBPART E
Subpart E - Surgical Devices
21:8.0.1.1.24.5.1.1SECTION 874.4100
   874.4100 Epistaxis balloon.
21:8.0.1.1.24.5.1.2SECTION 874.4140
   874.4140 Ear, nose, and throat bur.
21:8.0.1.1.24.5.1.3SECTION 874.4175
   874.4175 Nasopharyngeal catheter.
21:8.0.1.1.24.5.1.4SECTION 874.4180
   874.4180 Eustachian tube balloon dilation system.
21:8.0.1.1.24.5.1.5SECTION 874.4250
   874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
21:8.0.1.1.24.5.1.6SECTION 874.4350
   874.4350 Ear, nose, and throat fiberoptic light source and carrier.
21:8.0.1.1.24.5.1.7SECTION 874.4420
   874.4420 Ear, nose, and throat manual surgical instrument.
21:8.0.1.1.24.5.1.8SECTION 874.4490
   874.4490 Argon laser for otology, rhinology, and laryngology.
21:8.0.1.1.24.5.1.9SECTION 874.4500
   874.4500 Ear, nose, and throat microsurgical carbon dioxide laser.
21:8.0.1.1.24.5.1.10SECTION 874.4680
   874.4680 Bronchoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.11SECTION 874.4710
   874.4710 Esophagoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.12SECTION 874.4720
   874.4720 Mediastinoscope and accessories.
21:8.0.1.1.24.5.1.13SECTION 874.4750
   874.4750 Laryngostroboscope.
21:8.0.1.1.24.5.1.14SECTION 874.4760
   874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
21:8.0.1.1.24.5.1.15SECTION 874.4770
   874.4770 Otoscope.
21:8.0.1.1.24.5.1.16SECTION 874.4780
   874.4780 Intranasal splint.
21:8.0.1.1.24.5.1.17SECTION 874.4800
   874.4800 Bone particle collector.
21:8.0.1.1.24.6SUBPART F
Subpart F - Therapeutic Devices
21:8.0.1.1.24.6.1.1SECTION 874.5220
   874.5220 Ear, nose, and throat drug administration device.
21:8.0.1.1.24.6.1.2SECTION 874.5300
   874.5300 Ear, nose, and throat examination and treatment unit.
21:8.0.1.1.24.6.1.3SECTION 874.5350
   874.5350 Suction antichoke device.
21:8.0.1.1.24.6.1.4SECTION 874.5370
   874.5370 Tongs antichoke device.
21:8.0.1.1.24.6.1.5SECTION 874.5550
   874.5550 Powered nasal irrigator.
21:8.0.1.1.24.6.1.6SECTION 874.5800
   874.5800 External nasal splint.
21:8.0.1.1.24.6.1.7SECTION 874.5840
   874.5840 Antistammering device.
21:8.0.1.1.24.6.1.8SECTION 874.5900
   874.5900 External upper esophageal sphincter compression device.