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
501–525 of 2016
Cleared Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
K043090 · Phonic Ear, Inc.
LZI · Device, Assistive Listening · 45d
Cleared Nov 08, 2004
OTOMIMIX
K042516 · Walter Lorenz Surgical, Inc.
NEA · Cement, Ear, Nose And Throat · 53d
Cleared Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
K041381 · Medtronic Xomed, Inc.
LYA · Splint, Intranasal Septal · 108d
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 Apr 27, 2004
VISION SCIENCES MODEL ENT-2000V FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE
K040984 · Vision-Sciences, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 12d
Cleared Apr 01, 2004
NUVASIVE NEUROVISION JJB SYSTEM
K040543 · Nuvasive, Inc.
ETN · Stimulator, Nerve · 30d
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 20, 2004
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
K040018 · Boston Scientific Corp
EOQ · Bronchoscope (flexible Or Rigid) · 14d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · Gyrus Ent LLC
ETB · Prosthesis, Partial Ossicular Replacement · 12d
Cleared Oct 24, 2003
NUVASIVE NEUROVISION JJB SYSTEM
K032083 · Nuvasive, Inc.
ETN · Stimulator, Nerve · 109d
Cleared Oct 16, 2003
ENK FIBEROPTIC ATOMIZER SET
K031966 · Cook, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 112d
Cleared Sep 17, 2003
CRESCENT TINNITUS RETAINING SOUND GENERATOR
K030180 · Starkey Laboratories, Inc.
KLW · Masker, Tinnitus · 243d
Cleared Aug 05, 2003
TNE-2000 ESOPHAGOSCOPE WITH ECS-D ENDOSHEATH SYSTEM
K031786 · Vision-Sciences, Inc.
EOX · Esophagoscope (flexible Or Rigid) · 56d
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 Apr 11, 2003
STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES
K031003 · Medtronic Xomed, Inc.
ETN · Stimulator, Nerve · 11d
Cleared Jan 09, 2003
MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM
K024095 · Vision-Sciences, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 28d
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 Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
K021595 · Gyrus Ent LLC
ETN · Stimulator, Nerve · 162d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · Pentax Precision Instrument Corp.
EOQ · Bronchoscope (flexible Or Rigid) · 8d
Cleared Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · Vision-Sciences, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 342d

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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 ETA Replacement, Ossicular Prosthesis, Total 21