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

3823
Total
3806
Cleared
164d
Avg (2y)
1976
Since
3175 Ear, Nose, Throat devices
726–750 of 3175
Cleared Dec 31, 2008
CLEARVIEW ENDOSCOPE COVER
K080740 · Invotec International, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 289d
Cleared Dec 17, 2008
REPROCESSED ENT SHAVERS
K081814 · Sterilmed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 174d
Cleared Dec 09, 2008
GEL-SPONGE ENT, ABSORBABLE GELATIN SPONGE, USP
K080022 · Vascular Solutions, Inc.
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 341d
Cleared Nov 18, 2008
SYNTHEMED DEVICE
K082276 · Synthemed, Inc.
LYA · Splint, Intranasal Septal · 99d
Cleared Nov 14, 2008
OBC BONE ANCHORED HEARING AID SYSTEM
K082108 · Oticon Medical AB
LXB · Hearing Aid, Bone Conduction · 112d
Cleared Nov 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · Olympus Medical Systems Corporation
EOQ · Bronchoscope (flexible Or Rigid) · 49d
Cleared Oct 30, 2008
VISIONSENSE STEREOSCOPIC VISION SYSTEM (VS SYSTEM)
K082667 · Visionsense, Ltd.
EOB · Nasopharyngoscope (flexible Or Rigid) · 48d
Cleared Oct 20, 2008
Y-ADAPTER
K082174 · Asthmatx, Inc.
KTI · Bronchoscope Accessory · 80d
Cleared Oct 02, 2008
STRYKER ESSX WITH NAVIGATION MOUNT
K080052 · Stryker Corp.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 268d
Cleared Sep 19, 2008
DIZZYFIX
K081602 · Clearwater Clinical Limited
LXV · Apparatus, Vestibular Analysis · 105d
Cleared Sep 19, 2008
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc.
ETD · Tube, Tympanostomy · 46d
Cleared Sep 18, 2008
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV
K082245 · Ceremed , Inc.
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 42d
Cleared Sep 18, 2008
ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE
K082569 · Entellus Medical, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 13d
Cleared Sep 17, 2008
PRIMADO SURGICAL DRILL
K080722 · Nakanishi, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 188d
Cleared Sep 17, 2008
BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25
K081742 · Baxano, Inc.
ETN · Stimulator, Nerve · 90d
Cleared Sep 05, 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 123d
Cleared Sep 04, 2008
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES
K082206 · Helix Medical, LLC
EWL · Prosthesis, Laryngeal (taub) · 30d
Cleared Aug 28, 2008
BAHA INTENSO
K081606 · Cochlear Americas
LXB · Hearing Aid, Bone Conduction · 83d
Cleared Aug 26, 2008
STRYKER ESSX MICRODEBRIDER SYSTEM
K073633 · Stryker Ireland Ltd., Instruments Division
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 244d
Cleared Jul 18, 2008
AOC SOLUBLE IMPLANT MATERIAL
K081531 · Ceremed , Inc.
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 46d
Cleared Jul 16, 2008
AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER
K081841 · Amplivox, Ltd.
ETY · Tester, Auditory Impedance · 16d
Cleared Jul 14, 2008
GN OTOMETRICS INSERT EARPHONES
K081234 · Gn Otometrics
EWO · Audiometer · 74d
Cleared Jun 27, 2008
ZEN PROGRAM (MIND 440 HEARING AID)
K080955 · Widex Hearing Aid Co., Inc.
KLW · Masker, Tinnitus · 85d
Cleared Jun 27, 2008
MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM
K081542 · Entellus Medical, Inc.
LRC · Instrument, Ent Manual Surgical · 25d
Cleared Jun 20, 2008
EPLEY OMNIAX
K071973 · Vesticon
LXV · Apparatus, Vestibular Analysis · 339d

Looking for a specific ear, nose, throat device? Search by device name, K-number or manufacturer.

Search all Ear, Nose, Throat 510(k) devices

Filter by Product Code

All categories 3175 ESD Hearing Aid, Air-conduction, Prescription 1054 EOQ Bronchoscope (flexible Or Rigid) 215 EWO Audiometer 172 EOB Nasopharyngoscope (flexible Or Rigid) 157 ETD Tube, Tympanostomy 104 ETN Stimulator, Nerve 85 ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece 83 KLW Masker, Tinnitus 71 ETB Prosthesis, Partial Ossicular Replacement 66 LRC Instrument, Ent Manual Surgical 64 LXB Hearing Aid, Bone Conduction 53 ETY Tester, Auditory Impedance 53 ERA Otoscope 46 LYA Splint, Intranasal Septal 42 EMX Balloon, Epistaxis 39