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
351–375 of 488
Cleared Apr 05, 2018
PENTAX Medical EPK-3000 Video Imaging System
K172156 · Pentax Medical
EOB · Nasopharyngoscope (flexible Or Rigid) · 261d
Cleared Apr 02, 2018
K-D Balance
K173669 · King-Devick Technologies, Inc.
LXV · Apparatus, Vestibular Analysis · 123d
Cleared Mar 28, 2018
Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2
K173727 · Ambu A/S
EOQ · Bronchoscope (flexible Or Rigid) · 113d
Cleared Mar 27, 2018
OCM-G1 Attachment
K180063 · The Anspach Effort, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 77d
Cleared Mar 22, 2018
Monarch Endoscopy Platform (Monarch Platform)
K173760 · Auris Surgical Robotics, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 101d
Cleared Mar 10, 2018
Acclarent ENT Navigation System
K173628 · Acclarent, Inc.
PGW · Ear, Nose, And Throat Stereotaxic Instrument · 106d
Cleared Feb 21, 2018
Captura Disposable Bronchoscope Biopsy Forceps
K163377 · Wilson-Cook Medical, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 447d
Cleared Feb 16, 2018
SPIWay Endonasal Access Guide
K180141 · Spiway, LLC
LYA · Splint, Intranasal Septal · 29d
Cleared Feb 14, 2018
Sera
K173567 · Interacoustics A/S
EWO · Audiometer · 86d
Cleared Feb 02, 2018
KARL STORZ Slim Nasopharyngolaryngoscope
K171402 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 266d
Cleared Jan 19, 2018
FUJIFILM Bronchoscope Model EB-530P
K171291 · Fujifilm Medical Systems U.S.A, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 262d
Cleared Jan 19, 2018
PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope
K173554 · Pentax of America, Inc.
EOQ · Bronchoscope (flexible Or Rigid) · 63d
Cleared Jan 16, 2018
ACCLARENT AERA Eustachian Tube Balloon Dilation System
K171761 · Acclarent, Inc.
PNZ · Eustachian Tube Balloon Dilation Device · 216d
Cleared Sep 15, 2017
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K171840 · Stryker Corporation
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 87d
Cleared Jun 23, 2017
CRE Pulmonary Balloon Dilatation Catheter
K170759 · Boston Scientific Corporation
KTI · Bronchoscope Accessory · 102d
Cleared Apr 21, 2017
Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga
K163537 · Covidien, LLC
EOQ · Bronchoscope (flexible Or Rigid) · 126d
Cleared Mar 27, 2017
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K163248 · Boston Scientific Corporation
EOQ · Bronchoscope (flexible Or Rigid) · 129d
Cleared Mar 02, 2017
TIPCAM 1S 3D System
K162410 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 185d
Cleared Jan 17, 2017
Precision Thin Reciprocating Blade, 0.010in.
K161514 · Stryker Corporation
EQJ · Bur, Ear, Nose And Throat · 229d
Cleared Oct 21, 2016
KARL STORZ NAV1 Electromagnetic Navigation System
K161555 · KARL STORZ Endoscopy-America, Inc.
PGW · Ear, Nose, And Throat Stereotaxic Instrument · 137d
Cleared Sep 01, 2016
Elation Pulmonary Balloon Dilation
K161392 · Merit Medical Systems, Inc.
KTI · Bronchoscope Accessory · 105d
Cleared Jan 08, 2016
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K150969 · KARL STORZ Endoscopy-America, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 270d
Cleared Nov 10, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151315 · Boston Scientific Corporation
EOQ · Bronchoscope (flexible Or Rigid) · 176d
Cleared Oct 06, 2014
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
K141704 · Medtronic, Inc.
LYA · Splint, Intranasal Septal · 104d
Cleared Jun 28, 2012
CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM
K103467 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 582d

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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 ETN Stimulator, Nerve 11 PFO Active Implantable Bone Conduction Hearing System 11 LRC Instrument, Ent Manual Surgical 11 KTI Bronchoscope Accessory 10 EOX Esophagoscope (flexible Or Rigid) 9 QUH Self-fitting Air-conduction Hearing Aid, Over The Counter 9 KLW Masker, Tinnitus 8 NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable 8