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
3177 Ear, Nose, Throat devices
Cleared
Dec 06, 2005
GELITA-SPON
KHJ
Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
145d
Cleared
Nov 21, 2005
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
LYA
Splint, Intranasal Septal
110d
Cleared
Sep 21, 2005
VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT
EOB
Nasopharyngoscope (flexible Or Rigid)
15d
Cleared
Sep 15, 2005
NUVASIVE NEUROVISION JJB SYSTEM
ETN
Stimulator, Nerve
80d
Cleared
Aug 31, 2005
RELIEVA SINUS BALLOON INFLATION DEVICE
LRC
Instrument, Ent Manual Surgical
19d
Cleared
Aug 15, 2005
KARL STORZ TRANS-NASAL ESOPHAGOSCOPE
EOX
Esophagoscope (flexible Or Rigid)
25d
Cleared
Jul 11, 2005
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
KHJ
Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)
250d
Cleared
Jul 01, 2005
TRANSEAR BONE CONDUCTION HEARING AID
LXB
Hearing Aid, Bone Conduction
112d
Cleared
Jun 03, 2005
REPROCESSED TROCARS
KBG
Trocar, Sinus
568d
Cleared
May 19, 2005
FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-270P
EOQ
Bronchoscope (flexible Or Rigid)
38d
Cleared
May 16, 2005
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
NUP
Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
234d
Cleared
Apr 29, 2005
REM440
ETW
Calibrator, Hearing Aid / Earphone And Analysis Systems
60d
Cleared
Apr 29, 2005
VISION-SCIENCES ENT-3000 SCOPE
EOB
Nasopharyngoscope (flexible Or Rigid)
11d
Cleared
Apr 05, 2005
RELIEVA SINUS BALLOON DILATION CATHETER
LRC
Instrument, Ent Manual Surgical
105d
Cleared
Mar 03, 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
ETN
Stimulator, Nerve
37d
Cleared
Feb 10, 2005
EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
EOQ
Bronchoscope (flexible Or Rigid)
10d
Cleared
Feb 04, 2005
AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS
EWO
Audiometer
74d
Cleared
Jan 28, 2005
NEUROMONICS TINNITUS TREATMENT
KLW
Masker, Tinnitus
63d
Cleared
Jan 24, 2005
FISCH TITANIUM MIDDLE EAR PROSTHESES
ETA
Replacement, Ossicular Prosthesis, Total
47d
Cleared
Dec 23, 2004
EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
LZI
Device, Assistive Listening
45d
Cleared
Nov 22, 2004
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134
EWL
Prosthesis, Laryngeal (taub)
10d
Cleared
Nov 08, 2004
OTOMIMIX
NEA
Cement, Ear, Nose And Throat
53d
Cleared
Oct 01, 2004
KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM
ETA
Replacement, Ossicular Prosthesis, Total
16d
Cleared
Sep 10, 2004
CHIN-UP STRIP
LWF
Dilator, Nasal
197d
Cleared
Sep 10, 2004
MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT
LYA
Splint, Intranasal Septal
108d
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