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
526–550 of 2016
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · Bio-Logic Systems Corp.
EWO · Audiometer · 24d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · Vision-Sciences, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 25d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · Olympus America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 29d
Cleared Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · Boston Scientific Corp
KTI · Bronchoscope Accessory · 28d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · Gyrus Ent LLC
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 14d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc.
ETN · Stimulator, Nerve · 34d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 58d
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532 · Genzyme Corp.
LYA · Splint, Intranasal Septal · 85d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · Walter Lorenz Surgical, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 80d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 60d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · Biomet, Inc.
MIX · System, Vocal Cord Medialization · 39d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · Siemens Hearing Instruments, Inc.
KLW · Masker, Tinnitus · 34d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · Siemens Hearing Instruments, Inc.
KLW · Masker, Tinnitus · 28d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · Stryker Instruments
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 18d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · Siemens Hearing Instruments, Inc.
KLW · Masker, Tinnitus · 160d
Cleared Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · Siemens Hearing Instruments, Inc.
ESD · Hearing Aid, Air-conduction, Prescription · 158d
Cleared Apr 13, 2001
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc.
LYA · Splint, Intranasal Septal · 273d
Cleared Apr 13, 2001
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K003994 · KARL STORZ Endoscopy-America, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 108d
Cleared Oct 31, 2000
SMITH & NEPHEW PISTONS
K003214 · Gyrus Ent LLC
ETB · Prosthesis, Partial Ossicular Replacement · 18d
Cleared Oct 18, 2000
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 49d
Cleared Oct 17, 2000
XPS NITRO SYSTEM
K002828 · Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 36d
Cleared Oct 12, 2000
SMITH & NEPHEW PORPS & TORPS
K002737 · Gyrus Ent LLC
ETB · Prosthesis, Partial Ossicular Replacement · 41d
Cleared Oct 11, 2000
TITANIUM MIDDLE EAR PROSTHESES
K002897 · Xomed, Inc.
ETB · Prosthesis, Partial Ossicular Replacement · 23d
Cleared Aug 29, 2000
MODULAR PORP AND TORP MODEL TBD
K002378 · Gyrus Ent LLC
ETA · Replacement, Ossicular Prosthesis, Total · 25d
Cleared Aug 29, 2000
SMITH & NEPHEW OFF-CENTERED PORP
K002464 · Gyrus Ent LLC
ETB · Prosthesis, Partial Ossicular Replacement · 19d

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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 EWO Audiometer 55 LRC Instrument, Ent Manual Surgical 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