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

3179 Ear, Nose, Throat devices

876–900 of 3179

Cleared Oct 16, 2003

EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENT

K033225 · Olympus Optical Co., Ltd.

EOQ · Bronchoscope (flexible Or Rigid) · 10d

Cleared Sep 17, 2003

CRESCENT TINNITUS RETAINING SOUND GENERATOR

K030180 · Starkey Laboratories, Inc.

KLW · Masker, Tinnitus · 243d

Cleared Aug 12, 2003

AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS

K031713 · Viasys Healthcare, Inc.

EWO · Audiometer · 71d

Cleared Aug 05, 2003

TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM

K031786 · Vision-Sciences, Inc.

EOX · Esophagoscope (flexible Or Rigid) · 56d

Cleared Jul 24, 2003

K031624 · Tinnitus Control, Inc.

KLW · Masker, Tinnitus · 62d

Cleared Jul 24, 2003

VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V

K031648 · Olympus Optical Co., Ltd.

EOB · Nasopharyngoscope (flexible Or Rigid) · 57d

Cleared Jul 24, 2003

ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS

K031986 · Ics Medical

EWO · Audiometer · 27d

Cleared Jul 21, 2003

AMPLAID A756 SCREENING ADMITTANCE METER

K031978 · Amplaid

ETY · Tester, Auditory Impedance · 25d

Cleared Jul 16, 2003

BIO-LOGIC INSERT EARPHONES

K031352 · Bio-Logic Systems Corp.

EWO · Audiometer · 78d

Cleared Jul 02, 2003

SLIDE-ON ENDOSHEATH SYSTEM FOR SENSORY TESTING

K031790 · Vision-Sciences, Inc.

EOB · Nasopharyngoscope (flexible Or Rigid) · 22d

Cleared Jun 18, 2003

K031510 · Medtronic Xomed

ETN · Stimulator, Nerve · 35d

Cleared Apr 17, 2003

ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)

K030791 · Tinnitech, Ltd.

KLW · Masker, Tinnitus · 36d

Cleared Apr 11, 2003

STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES

K031003 · Medtronic Xomed, Inc.

ETN · Stimulator, Nerve · 11d

Cleared Apr 01, 2003

HENKE SASS WOLF OF AMERICA NASOPHARYNGOSCOPE

K030572 · Henke Sass Wolf of America, Inc.

EOB · Nasopharyngoscope (flexible Or Rigid) · 36d

Cleared Mar 28, 2003

MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C

K022446 · Aomori Olympus Co., Ltd.

EOQ · Bronchoscope (flexible Or Rigid) · 246d

Cleared Mar 28, 2003

K030016 · Interacoustics A/S, Assens

EWO · Audiometer · 85d

Cleared Mar 07, 2003

AUDIOSCREENER OAE+ABR

K024205 · Everest Biomedical Instruments Co.

EWO · Audiometer · 77d

Cleared Mar 03, 2003

TITANIUM OSSICULAR REPLACMENT SYSTEM

K030492 · Invotec International, Inc.

ETA · Replacement, Ossicular Prosthesis, Total · 12d

Cleared Jan 31, 2003

MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES

K023984 · The Olympus Optical Co.

EOQ · Bronchoscope (flexible Or Rigid) · 60d

Cleared Jan 28, 2003

LFRE INDIRECT LARYNGOSCOPE

K023004 · Astralite Corp.

EOB · Nasopharyngoscope (flexible Or Rigid) · 141d

Cleared Jan 28, 2003

SODEM HIGH SPEED SYSTEM (PNEUMATIC)

K023070 · Sodemsystems

ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 134d

Cleared Jan 10, 2003

DUAL-LUMEN CATHETER

K024165 · Bistech, Inc.

EOQ · Bronchoscope (flexible Or Rigid) · 24d

Cleared Jan 09, 2003

MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM

K024095 · Vision-Sciences, Inc.

EOB · Nasopharyngoscope (flexible Or Rigid) · 28d

Cleared Jan 08, 2003

K023859 · Intelligent Hearing Systems

EWO · Audiometer · 49d

Cleared Dec 03, 2002

DAUM-LECTRIC MRI DRILLING MACHINE

K021098 · Mri Devices Daum GmbH

ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 243d

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