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
Cleared
Nov 19, 2002
INSOUND XT SERIES HEARING AID
ESD
Hearing Aid, Air-conduction, Prescription
166d
Cleared
Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
KTI
Bronchoscope Accessory
42d
Cleared
Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
ETN
Stimulator, Nerve
162d
Cleared
Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
EOQ
Bronchoscope (flexible Or Rigid)
8d
Cleared
Oct 11, 2002
REUSABLE BRONCHIAL BIOPSY FORCEPS
BWH
Forceps, Biopsy, Bronchoscope (non-rigid)
80d
Cleared
Oct 11, 2002
AUDIOTRAVELLER, MODEL AA222
ETY
Tester, Auditory Impedance
56d
Cleared
Oct 09, 2002
REPROCESSED DISPOSABLE TROCARS
KAB
Trocar, Laryngeal
51d
Cleared
Oct 01, 2002
SNIFF POSITION PILLOWS/POPITZ PILLOWS
MYB
Pillow, Cervical (for Mild Sleep Apnea)
22d
Cleared
Aug 30, 2002
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
LXB
Hearing Aid, Bone Conduction
87d
Cleared
Aug 27, 2002
FONIX, MODEL 7000
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
28d
Not Cleared
Aug 20, 2002
RETROX
NIX
Hearing Aid, Air Conduction, Transcutaneous System
60d
Cleared
Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
EOQ
Bronchoscope (flexible Or Rigid)
11d
Cleared
Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
EWL
Prosthesis, Laryngeal (taub)
29d
Cleared
Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
EOB
Nasopharyngoscope (flexible Or Rigid)
342d
Cleared
Jul 13, 2002
ULTRAQUIET
KLW
Masker, Tinnitus
88d
Cleared
Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
EWO
Audiometer
24d
Cleared
Jun 25, 2002
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
EWD
Protector, Hearing (insert)
148d
Cleared
Jun 19, 2002
UNIDRIVE II PLUS DISPOSABLE TUBING SET
ERL
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
16d
Cleared
May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
EOQ
Bronchoscope (flexible Or Rigid)
25d
Cleared
May 21, 2002
TST - SUPPRESSOR MODEL #1000
KLW
Masker, Tinnitus
183d
Cleared
May 21, 2002
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
ETB
Prosthesis, Partial Ossicular Replacement
13d
Cleared
May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
EOB
Nasopharyngoscope (flexible Or Rigid)
29d
Cleared
Apr 17, 2002
NICOLET ELECTROCAUTERY DETECTOR
ETN
Stimulator, Nerve
23d
Cleared
Apr 05, 2002
HISONIC-TRD TINNITUS RELIEF DEVICE
KLW
Masker, Tinnitus
189d
Cleared
Apr 05, 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
KTI
Bronchoscope Accessory
28d
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