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
3177 Ear, Nose, Throat devices
851–875 of 3177
Cleared Sep 03, 2004
OTOGRAM
K041853 · Tympany, Inc.
ETW · Calibrator, Hearing Aid / Earphone And Analysis Systems · 57d
Cleared Aug 26, 2004
BAHA DIVINO
K042017 · Entific Medical Systems, Inc.
LXB · Hearing Aid, Bone Conduction · 30d
Cleared Aug 20, 2004
RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM
K040996 · Gyrus Ent LLC
NIX · Hearing Aid, Air Conduction, Transcutaneous System · 126d
Cleared Aug 12, 2004
XPS CURVED BUR
K041985 · Medtronic Xomed, Inc.
EQJ · Bur, Ear, Nose And Throat · 20d
Cleared Jul 23, 2004
XPS 3000 SYSTEM
K041523 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 45d
Cleared Jul 12, 2004
XPS 3000 SYSTEM
K041413 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 46d
Cleared Jul 01, 2004
REFUGE SOUND GENERATOR
K041302 · Micro-Ear Technology, Inc.
KLW · Masker, Tinnitus · 48d
Cleared Jul 01, 2004
NASALCEASE
K041446 · Les Laboratorires Brothier, S.A.
EMX · Balloon, Epistaxis · 30d
Cleared Apr 30, 2004
SONA PILLOW
K040161 · Sleep Devices, Inc.
MYB · Pillow, Cervical (for Mild Sleep Apnea) · 98d
Cleared Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · Vision-Sciences, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 12d
Cleared Apr 19, 2004
BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM
K040940 · Olympus Corporation
EOQ · Bronchoscope (flexible Or Rigid) · 7d
Cleared Apr 12, 2004
QUIESCENCE
K040330 · Spectral Visualization & Development, Inc.
KLW · Masker, Tinnitus · 61d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc.
ETN · Stimulator, Nerve · 30d
Cleared Mar 31, 2004
OTOFLEX 100 TYE 1012
K033645 · Gn Otometrics A/S
ETY · Tester, Auditory Impedance · 132d
Cleared Mar 03, 2004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K034004 · Gyrus Ent LLC
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 70d
Cleared Mar 03, 2004
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K040300 · Stryker Instruments
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 23d
Cleared Jan 30, 2004
KURZ SILICONE STRIPS, MODELS SF-1, SF-1W, SF-1 BS
K033796 · Heinz Kurz GmbH Medizintechnik
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 56d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp
EOQ · Bronchoscope (flexible Or Rigid) · 14d
Cleared Jan 08, 2004
ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
K032822 · Asap Endoscopic Products GmbH
EOB · Nasopharyngoscope (flexible Or Rigid) · 120d
Cleared Dec 12, 2003
LARYNGEAL AUGMENTATION IMPLANT
K033398 · Bioform, Inc.
MIX · System, Vocal Cord Medialization · 49d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC
ETB · Prosthesis, Partial Ossicular Replacement · 12d
Cleared Oct 27, 2003
VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER
K033108 · Vivosonic, Inc.
EWO · Audiometer · 27d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc.
ETN · Stimulator, Nerve · 109d
Cleared Oct 16, 2003
MAHE PEDIATRIC NASO PHARYNGOSCOPE ITS ASSOCIATED AND ANCILLARY EQUIPMENT AND ENDOSCOPIC ACCESSORIES
K030857 · Mahe Intl., Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 212d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 112d

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All categories 3177 ESD Hearing Aid, Air-conduction, Prescription 1055 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 ETY Tester, Auditory Impedance 53 LXB Hearing Aid, Bone Conduction 53 ERA Otoscope 46 LYA Splint, Intranasal Septal 42 EMX Balloon, Epistaxis 39