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
3179 Ear, Nose, Throat devices
951–975 of 3179
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · Biomet, Inc.
MIX · System, Vocal Cord Medialization · 39d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · Ics Medical Corp.
EWO · Audiometer · 68d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · Durect Corp.
ETD · Tube, Tympanostomy · 49d
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 May 08, 2001
EXHALE RF PROBE
K011267 · Broncus Technologies, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 12d
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 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · Uromed Corp.
ETN · Stimulator, Nerve · 87d
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 Apr 09, 2001
ENT ENDOSCOPES
K003830 · Global Endoscopy, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 119d
Cleared Mar 16, 2001
HINT AUDIOMETER, OR HINT
K003913 · Maico-Diagnostics
EWO · Audiometer · 87d
Cleared Mar 12, 2001
ERO SCAN OAE TEST SYSTEM
K010165 · Etymotic Research
EWO · Audiometer · 53d
Cleared Mar 08, 2001
KURZ ANGULAR PISTON-TITANIUM PROSTHESIS, MODELS 1006 600, 1006 601, 1006 602, 1006 650, 1006 651, 1006 652
K010442 · Heinz Kurz
ETB · Prosthesis, Partial Ossicular Replacement · 22d
Cleared Feb 12, 2001
SERENOCEM, MODEL BC 010
K003567 · Corinthian Medical , Ltd.
NEA · Cement, Ear, Nose And Throat · 84d
Cleared Jan 16, 2001
LARYNGEAL SURFACE ELECTRODE-ENDOTRACHEAL TUBE, M-500-ET, LSE-ET
K003745 · Rln Systems, Inc.
ETN · Stimulator, Nerve · 43d
Cleared Dec 15, 2000
MEROGEL CONTROL GEL ENT SURGICAL DRESSING
K002972 · Medtronic Xomed
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 84d
Cleared Dec 04, 2000
XPS 3000 SYSTEM
K002224 · Medtronic Xomed
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 133d
Cleared Nov 21, 2000
SINUSCOPE AND BACCESSORIES
K002214 · Pollux Endoscopy, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 120d
Cleared Nov 20, 2000
SILMAX CONTOUR CARVING BLOCK IMPLANT
K002629 · Pillar Surgical, Inc.
JOF · Polymer, Ent Synthetic, Porous Polyethylene · 89d
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

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All categories 3179 ESD Hearing Aid, Air-conduction, Prescription 1056 EOQ Bronchoscope (flexible Or Rigid) 215 EWO Audiometer 173 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 LXB Hearing Aid, Bone Conduction 53 ETY Tester, Auditory Impedance 53 ERA Otoscope 46 LYA Splint, Intranasal Septal 42 EMX Balloon, Epistaxis 39