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
3175 Ear, Nose, Throat devices
Cleared
Aug 22, 2011
RELIEVA SOLO ELITE SINUS BALLOON CATHETER
LRC
Instrument, Ent Manual Surgical
110d
Cleared
Jul 07, 2011
NEURO CHECK DEVICE WITH IO-FLEX WIRE
ETN
Stimulator, Nerve
115d
Cleared
Jun 28, 2011
DRYTOUCH SUCTION STIMULATOR PROBE
ETN
Stimulator, Nerve
106d
Cleared
Jun 21, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL
LXB
Hearing Aid, Bone Conduction
88d
Cleared
Jun 15, 2011
PONTO PRO POWER
LXB
Hearing Aid, Bone Conduction
189d
Cleared
Jun 14, 2011
ENTELLUS MEDICAL SINUS GUIDEWIRE
LRC
Instrument, Ent Manual Surgical
89d
Cleared
Jun 07, 2011
ILLUMINATING SINUS SEEKER
LRC
Instrument, Ent Manual Surgical
139d
Cleared
May 27, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
EOB
Nasopharyngoscope (flexible Or Rigid)
134d
Cleared
May 26, 2011
SURGICAL STIMULATORS
ETN
Stimulator, Nerve
101d
Cleared
May 23, 2011
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M)
LXB
Hearing Aid, Bone Conduction
292d
Cleared
May 18, 2011
VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR
EOB
Nasopharyngoscope (flexible Or Rigid)
238d
Cleared
May 10, 2011
BAHA 3 POWER SOUND PROCESSOR
LXB
Hearing Aid, Bone Conduction
29d
Cleared
May 05, 2011
IE-ZEN (IN CLEAR SERIES HEARING AID)
KLW
Masker, Tinnitus
29d
Cleared
May 03, 2011
TINNITUS SOUND GENERATOR MODULE
KLW
Masker, Tinnitus
29d
Cleared
Apr 28, 2011
GN OTOMETRICS TYPE 1053 FREEFIT
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
87d
Cleared
Apr 08, 2011
ACAM 5 AUDIOMETER SYSTEM
EWO
Audiometer
151d
Cleared
Apr 08, 2011
PAIRED HYDROGEL ELECTRODE
ETN
Stimulator, Nerve
80d
Cleared
Apr 01, 2011
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
ETD
Tube, Tympanostomy
114d
Cleared
Mar 31, 2011
INSPIRA AIR BALLOON DILATION SYSTEM
KTI
Bronchoscope Accessory
65d
Not Cleared
Mar 31, 2011
WIDEXLINK IN CLEAR SERIES HEARING AIDS
OSM
Hearing Aid, Air-conduction With Wireless Technology, Prescription
169d
Cleared
Feb 23, 2011
CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE,
ETN
Stimulator, Nerve
121d
Cleared
Feb 15, 2011
FINESS ENDOSCOPE
EOB
Nasopharyngoscope (flexible Or Rigid)
179d
Cleared
Jan 24, 2011
RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS
BWH
Forceps, Biopsy, Bronchoscope (non-rigid)
159d
Cleared
Jan 14, 2011
SOUNDBITE HEARING SYSTEM BY SONITUS
LXB
Hearing Aid, Bone Conduction
312d
Cleared
Jan 06, 2011
ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
EOB
Nasopharyngoscope (flexible Or Rigid)
311d
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