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
926–950 of 3179
Cleared Mar 13, 2002
MTP CLEARVISION DISPOSABLE TUBING SET
K020599 · Mtp Medical Technical Promotion GmbH
EOB · Nasopharyngoscope (flexible Or Rigid) · 19d
Cleared Mar 08, 2002
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K020594 · Gyrus Ent LLC
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 14d
Cleared Mar 01, 2002
REPROCESSED DISPOSABLE TROCARS
K013987 · Adven Medical
KBG · Trocar, Sinus · 87d
Cleared Jan 22, 2002
STIMULUS - DISSECTION INSTRUMENTS
K014165 · Medtronic Xomed, Inc.
ETN · Stimulator, Nerve · 34d
Cleared Jan 16, 2002
KSEA CLEARVISION LENS IRRIGATION SYSTEM
K013838 · KARL STORZ Endoscopy-America, Inc.
EOB · Nasopharyngoscope (flexible Or Rigid) · 58d
Cleared Jan 09, 2002
COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1
K013243 · Bioform, Inc.
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 103d
Cleared Dec 26, 2001
XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLARY EQUIPMENT
K013591 · Olympus Optical Co., Ltd.
EOB · Nasopharyngoscope (flexible Or Rigid) · 57d
Cleared Nov 28, 2001
SILMED NASAL SEPTAL BUTTON
K013696 · Silmed, Inc.
LFB · Button, Nasal Septal · 21d
Cleared Nov 27, 2001
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71
K013731 · Gimmi GmbH
EOQ · Bronchoscope (flexible Or Rigid) · 18d
Cleared Nov 09, 2001
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257
K013573 · Heinz Kurz GmbH Medizintechnik
ETB · Prosthesis, Partial Ossicular Replacement · 11d
Cleared Oct 30, 2001
SEPRAGEL SINUS
K012532 · Genzyme Corp.
LYA · Splint, Intranasal Septal · 85d
Cleared Oct 25, 2001
MACROPORE ENT RECONSTRUCTION FILM
K012769 · Macropore Biosurgery, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 69d
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · Walter Lorenz Surgical, Inc.
NHB · Polymer, Ear, Nose And Throat, Synthetic, Absorbable · 80d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306 · Etymonic Design, Inc.
ETW · Calibrator, Hearing Aid / Earphone And Analysis Systems · 60d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · Sodemsystems
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 51d
Cleared Sep 13, 2001
OTO-CEM
K011338 · Ototech, Inc.
NEA · Cement, Ear, Nose And Throat · 134d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · Seikagaku Corp.
LYA · Splint, Intranasal Septal · 89d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · The Olympus Optical Co.
EOQ · Bronchoscope (flexible Or Rigid) · 39d
Cleared Jul 26, 2001
GSI AUDERA
K011135 · Nicolet Biomedical
EWO · Audiometer · 104d
Cleared Jul 25, 2001
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K011869 · The Olympus Optical Co.
EOB · Nasopharyngoscope (flexible Or Rigid) · 41d
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · Entific Medical Systems, Inc.
LXB · Hearing Aid, Bone Conduction · 74d
Cleared Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364 · Vivosonic, Inc.
EWO · Audiometer · 264d
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855 · Fidia Advanced Biopolymers Srl
KHJ · Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) · 202d
Cleared Jul 03, 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · Etymotic Research
EWO · Audiometer · 82d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · Medtronic Xomed, Inc.
ERL · Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece · 60d

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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 ETY Tester, Auditory Impedance 53 LXB Hearing Aid, Bone Conduction 53 ERA Otoscope 46 LYA Splint, Intranasal Septal 42 EMX Balloon, Epistaxis 39