Title 21, Part 874 — Ear, Nose, and Throat Devices
67 sections
Section 874.1
Scope.
Section 874.3
Effective dates of requirement for premarket approval.
Section 874.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
Section 874.1050
Audiometer.
Section 874.1060
Acoustic chamber for audiometric testing.
Section 874.1070
Short increment sensitivity index (SISI) adapter.
Section 874.1080
Audiometer calibration set.
Section 874.1090
Auditory impedance tester.
Section 874.1100
Earphone cushion for audiometric testing.
Section 874.1120
Electronic noise generator for audiometric testing.
Section 874.1325
Electroglottograph.
Section 874.1500
Gustometer.
Section 874.1600
Olfactory test device.
Section 874.1800
Air or water caloric stimulator.
Section 874.1820
Surgical nerve stimulator/locator.
Section 874.1925
Toynbee diagnostic tube.
Section 874.3300
Air-conduction hearing aid.
Section 874.3302
Bone-conduction hearing aid.
Section 874.3305
Wireless air-conduction hearing aid.
Section 874.3310
Hearing aid calibrator and analysis system.
Section 874.3315
Tympanic membrane contact hearing aid.
Section 874.3320
Group hearing aid or group auditory trainer.
Section 874.3325
Self-fitting air-conduction hearing aid.
Section 874.3330
Master hearing aid.
Section 874.3340
Active implantable bone conduction hearing system.
Section 874.3375
Battery-powered artificial larynx.
Section 874.3400
Tinnitus masker.
Section 874.3430
Middle ear mold.
Section 874.3450
Partial ossicular replacement prosthesis.
Section 874.3495
Total ossicular replacement prosthesis.
Section 874.3540
Prosthesis modification instrument for ossicular replacement surgery.
Section 874.3620
Ear, nose, and throat synthetic polymer material.
Section 874.3695
Mandibular implant facial prosthesis.
Section 874.3730
Laryngeal prosthesis (Taub design).
Section 874.3760
Sacculotomy tack (Cody tack)
Section 874.3820
Endolymphatic shunt.
Section 874.3850
Endolymphatic shunt tube with valve.
Section 874.3880
Tympanostomy tube.
Section 874.3900
Nasal dilator.
Section 874.3930
Tympanostomy tube with semipermeable membrane.
Section 874.3950
Transcutaneous air conduction hearing aid system.
Section 874.4100
Epistaxis balloon.
Section 874.4140
Ear, nose, and throat bur.
Section 874.4175
Nasopharyngeal catheter.
Section 874.4180
Eustachian tube balloon dilation system.
Section 874.4250
Ear, nose, and throat electric or pneumatic surgical drill.
Section 874.4350
Ear, nose, and throat fiberoptic light source and carrier.
Section 874.4420
Ear, nose, and throat manual surgical instrument.
Section 874.4450
Powered insertion system for a cochlear implant electrode array.
Section 874.4490
Argon laser for otology, rhinology, and laryngology.
Section 874.4500
Ear, nose, and throat microsurgical carbon dioxide laser.
Section 874.4680
Bronchoscope (flexible or rigid) and accessories.
Section 874.4710
Esophagoscope (flexible or rigid) and accessories.
Section 874.4720
Mediastinoscope and accessories.
Section 874.4750
Laryngostroboscope.
Section 874.4760
Nasopharyngoscope (flexible or rigid) and accessories.
Section 874.4770
Otoscope.
Section 874.4780
Intranasal splint.
Section 874.4800
Bone particle collector.
Section 874.5220
Ear, nose, and throat drug administration device.
Section 874.5300
Ear, nose, and throat examination and treatment unit.
Section 874.5350
Suction antichoke device.
Section 874.5370
Tongs antichoke device.
Section 874.5550
Powered nasal irrigator.
Section 874.5800
External nasal splint.
Section 874.5840
Antistammering device.
Section 874.5900
External upper esophageal sphincter compression device.