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
451–475 of 2016
Cleared Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
K110218 · Acclarent, Inc.
KTI · Bronchoscope Accessory · 65d
Cleared Feb 15, 2011
FINESS ENDOSCOPE
K102366 · Entellus Medical, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 179d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · Boston Scientific Corporation
BWH · Forceps, Biopsy, Bronchoscope (non-rigid) · 159d
Cleared Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
K100577 · Acclarent, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 311d
Cleared Oct 22, 2010
XPRESS BALLOON DEVICE
K102003 · Entellus Medical, Inc.
LRC · Instrument, Ent Manual Surgical · 99d
Cleared Feb 25, 2010
VISION SCIENCES FLEXIBLE ENT SCOPE
K100125 · Vision-Sciences, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 37d
Cleared Feb 17, 2010
PDS PLATES
K092590 · Ethicon, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 177d
Cleared Feb 05, 2010
ENTELLUS MEDICAL BALLOON DEVICE
K093007 · Entellus Medical, Inc.
LRC · Instrument, Ent Manual Surgical · 130d
Cleared Sep 14, 2009
RUTTER SUPRA STOMAL STENTS
K091135 · Boston Medical Products, Inc.
FWN · Prosthesis, Larynx (stents And Keels) · 147d
Cleared Aug 03, 2009
VIDEO SCIENCES BRS-5000 VIDEO BRONCHOSCOPE WITH ENDOSHEATH SYSTEM, DPU-5000/DPU-5050 VIDEO PROCESSOR & ACCESSORIES
K091768 · Vision-Sciences, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 48d
Cleared Jul 08, 2009
FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
K091681 · Entellus Medical, Inc.
LRC · Instrument, Ent Manual Surgical · 28d
Cleared Jun 12, 2009
AIRWAY BALLOON CATHETER INFLATION DEVICE
K090660 · Acclarent, Inc.
KTI · Bronchoscope Accessory · 92d
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 05, 2008
TRACHEAL INTUBATION FIBERVIDEOSCOPE, MODELS LF-Y0004 AND LF-Y0005
K082720 · Olympus Medical Systems Corporation
EOQ · Bronchoscope (flexible Or Rigid) · 49d
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
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc.
ETD · Tube, Tympanostomy · 46d
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 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 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 Apr 08, 2008
ENTELLUS MEDICAL RS-SERIES SYSTEM
K072302 · Entellus Medical, Inc.
LRC · Instrument, Ent Manual Surgical · 235d
Cleared Mar 24, 2008
XPS 3000 SYSTEM
K073255 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 126d
Cleared Mar 14, 2008
EARPOPPER, MODEL EP-2000, EP-2100, EP-3000
K073401 · Micromedics, Inc.
MJV · Device, Inflation, Middle Ear · 101d

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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 PGW Ear, Nose, And Throat Stereotaxic Instrument 25 EQH Source, Carrier, Fiberoptic Light 25 ETF Unit, Examining/treatment, Ent 24 KLW Masker, Tinnitus 22 EPF Hearing Aid, Group And Auditory Trainer 21