FDA Review Panel · EN

FDA 510(k) Ear, Nose & Throat Devices

FDA 510(k) Ear, Nose, Throat Devices - Regulatory Overview

FDA 510(k) ear, nose and throat (ENT) devices cover diagnostic and therapeutic equipment used in otolaryngology. The FDA review panel code is EN.

This category includes:

  • Hearing aids and amplifiers - air conduction, bone conduction and CROS systems
  • Cochlear implants - Class III devices (typically PMA, some 510k predicate paths)
  • ENT endoscopes - rigid and flexible nasopharyngoscopes, laryngoscopes
  • Surgical instruments - microdebriders, powered ENT systems
  • Audiometric systems - audiometers, tympanometers, OAE devices

3812
Total
3795
Cleared
160d
Avg (2y)
1976
Since
2016 Ear, Nose, Throat devices
2001–2016 of 2016
Cleared Jan 21, 1977
ROBBETT MICROSURGICAL LARYNGOSCOPE
K770085 · Edward Weck, Inc.
EQN · Laryngoscope, Nasopharyngoscope · 7d
Cleared Jan 18, 1977
MIRROR, LARYNGEAL
K770053 · Welch Allyn, Inc.
KAI · Mirror, Ent · 8d
Cleared Jan 18, 1977
MIRROR, NASO-PHARYNX
K770054 · Welch Allyn, Inc.
KAI · Mirror, Ent · 8d
Cleared Dec 16, 1976
JESBERG ESOPHAGOSCOPES W/AUSTINETIC S S
K760652 · Pilling Co.
EOX · Esophagoscope (flexible Or Rigid) · 92d
Cleared Dec 16, 1976
WIDEX HEARING AID MODEL F8
K761223 · Widex Hearing Aid Co., Inc.
ESD · Hearing Aid, Air-conduction, Prescription · 8d
Cleared Dec 06, 1976
ADAPTER/STANDARD FIBER OPTICS LIGHT
K760653 · Pilling Co.
EQH · Source, Carrier, Fiberoptic Light · 81d
Cleared Dec 02, 1976
WIDEX HEARING AID MODEL F7H & F7T
K761103 · Widex Hearing Aid Co., Inc.
ESD · Hearing Aid, Air-conduction, Prescription · 14d
Cleared Nov 16, 1976
HEARING AID (MODEL 695D, 905 & 960P)
K760996 · Unitron Industries, Inc.
ESD · Hearing Aid, Air-conduction, Prescription · 8d
Cleared Nov 03, 1976
COMPRESSION ADJUSTRETTE
K760887 · Qualitone
ESD · Hearing Aid, Air-conduction, Prescription · 12d
Cleared Oct 05, 1976
SHEA TORP, OTOLOGY IMPLANT
K760433 · Richard'S Medical Equip., Inc.
ETA · Replacement, Ossicular Prosthesis, Total · 50d
Cleared Oct 05, 1976
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
K760434 · Richard'S Medical Equip., Inc.
ETB · Prosthesis, Partial Ossicular Replacement · 50d
Cleared Oct 05, 1976
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
K760437 · Richard'S Medical Equip., Inc.
ETB · Prosthesis, Partial Ossicular Replacement · 50d
Cleared Sep 27, 1976
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
K760435 · Richard'S Medical Equip., Inc.
ETB · Prosthesis, Partial Ossicular Replacement · 42d
Cleared Sep 27, 1976
PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
K760439 · Richard'S Medical Equip., Inc.
ETD · Tube, Tympanostomy · 42d
Cleared Sep 21, 1976
SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
K760438 · Richard'S Medical Equip., Inc.
ETD · Tube, Tympanostomy · 36d
Cleared Jul 19, 1976
FIBERBRONCHOSCOPE (PENTAX FB-17A)
K760171 · Pilling Co.
EOQ · Bronchoscope (flexible Or Rigid) · 13d

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All categories 2016 ESD Hearing Aid, Air-conduction, Prescription 740 EOQ Bronchoscope (flexible Or Rigid) 177 EOB Nasopharyngoscope (flexible Or Rigid) 106 ETD Tube, Tympanostomy 68 ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece 58 LRC Instrument, Ent Manual Surgical 55 EWO Audiometer 55 ETN Stimulator, Nerve 38 ETB Prosthesis, Partial Ossicular Replacement 37 ERA Otoscope 30 EQH Source, Carrier, Fiberoptic Light 25 PGW Ear, Nose, And Throat Stereotaxic Instrument 25 ETF Unit, Examining/treatment, Ent 24 KLW Masker, Tinnitus 22 ETA Replacement, Ossicular Prosthesis, Total 21