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

3798
Total
3781
Cleared
166d
Avg (2y)
1976
Since
488 Ear, Nose, Throat devices
376–400 of 488
Cleared May 16, 2012
RADIAL JAW 4 PULMONARY BIOPSY FORCEPS
K121186 · Boston Scientific Corp
BWH · Forceps, Biopsy, Bronchoscope (non-rigid) · 28d
Cleared Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
K102336 · Boston Scientific Corporation
BWH · Forceps, Biopsy, Bronchoscope (non-rigid) · 159d
Cleared Feb 17, 2010
PDS PLATES
K092590 · Ethicon, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 177d
Cleared Sep 13, 2007
KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES
K072387 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 20d
Cleared Aug 24, 2007
KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM
K071530 · KARL STORZ Endoscopy-America, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 80d
Cleared May 01, 2007
KSEA MINIATURE ENDOSCOPE, MODEL 11565
K070752 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 43d
Cleared Apr 26, 2007
MEROGEL INJECTABLE BIORESORBABLE STENT
K070886 · Medtronic, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 27d
Cleared Dec 19, 2005
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · KARL STORZ Endoscopy-America, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 27d
Cleared Aug 15, 2005
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
K051972 · KARL STORZ Endoscopy-America, Inc.
EOX · Esophagoscope (flexible Or Rigid) · 25d
Cleared Jan 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp
EOQ · Bronchoscope (flexible Or Rigid) · 14d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 112d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
K023337 · Boston Scientific Corp
KTI · Bronchoscope Accessory · 42d
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 Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 58d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · Biomet, Inc.
MIX · System, Vocal Cord Medialization · 39d
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 18, 2000
KSEA UNIMAT 12
K002700 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 49d
Cleared Jul 26, 2000
VOCOM SILICONE SYSTEM
K001466 · Smith & Nephew, Inc.
MIX · System, Vocal Cord Medialization · 77d
Cleared Mar 01, 2000
VOCOM IMPLANT- 8MM
K000533 · Smith & Nephew, Inc.
MIX · System, Vocal Cord Medialization · 13d
Cleared Jan 29, 1999
DCI ENDOSCOPE
K984369 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 53d
Cleared Dec 10, 1998
GORE REVOX THYROPLASTY IMPLANT
K983525 · W.L. Gore & Associates, Inc.
MIX · System, Vocal Cord Medialization · 63d
Cleared Jan 26, 1998
RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
K973875 · Respironics, Inc.
KMA · Irrigator, Powered Nasal · 108d
Cleared Sep 08, 1997
KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES
K972855 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 38d
Cleared Mar 21, 1997
SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE
K970247 · Smith & Nephew, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 58d

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All categories 488 EOQ Bronchoscope (flexible Or Rigid) 120 EOB Nasopharyngoscope (flexible Or Rigid) 65 PGW Ear, Nose, And Throat Stereotaxic Instrument 20 ESD Hearing Aid, Air-conduction, Prescription 18 BTA Pump, Portable, Aspiration (manual Or Powered) 16 GEI Electrosurgical, Cutting & Coagulation & Accessories 14 ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece 13 LRC Instrument, Ent Manual Surgical 11 ETN Stimulator, Nerve 11 PFO Active Implantable Bone Conduction Hearing System 11 KTI Bronchoscope Accessory 10 QUH Self-fitting Air-conduction Hearing Aid, Over The Counter 9 EOX Esophagoscope (flexible Or Rigid) 9 ETD Tube, Tympanostomy 8 LXB Hearing Aid, Bone Conduction 8