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
3180 Ear, Nose, Throat devices
Cleared
Dec 15, 1997
OPUS 2 - CANAL SERIES (ITC)
ESD
Hearing Aid, Air-conduction, Prescription
48d
Cleared
Dec 15, 1997
OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC)
ESD
Hearing Aid, Air-conduction, Prescription
41d
Cleared
Dec 15, 1997
OPUS 2 - FULL CONCHA SERIES - ITE
ESD
Hearing Aid, Air-conduction, Prescription
35d
Cleared
Dec 12, 1997
SHAH PERMAVENT
ETD
Tube, Tympanostomy
52d
Cleared
Dec 12, 1997
RESOUND STEALTH CIC
ESD
Hearing Aid, Air-conduction, Prescription
44d
Cleared
Dec 12, 1997
HI-69E, HI-69N, HI-69P
ESD
Hearing Aid, Air-conduction, Prescription
39d
Cleared
Dec 12, 1997
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
ESD
Hearing Aid, Air-conduction, Prescription
29d
Cleared
Dec 12, 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
ESD
Hearing Aid, Air-conduction, Prescription
24d
Cleared
Dec 12, 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
ESD
Hearing Aid, Air-conduction, Prescription
24d
Cleared
Dec 12, 1997
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
ESD
Hearing Aid, Air-conduction, Prescription
24d
Cleared
Dec 11, 1997
HYUNJAE CORPORATION - NUSIL EARMOLD IMPRESSION MATERIAL
ESD
Hearing Aid, Air-conduction, Prescription
57d
Cleared
Nov 25, 1997
ARTICULATE FITTING SYSTEM
EWO
Audiometer
83d
Cleared
Nov 21, 1997
FLEXTIP GRASPER
EOB
Nasopharyngoscope (flexible Or Rigid)
144d
Cleared
Nov 21, 1997
K-PISTON WITH BAND HOOK /ANGULAR PISTON
ETB
Prosthesis, Partial Ossicular Replacement
74d
Cleared
Nov 19, 1997
FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48
ESD
Hearing Aid, Air-conduction, Prescription
41d
Cleared
Nov 18, 1997
INTUBATION ENDOSCOPE AND INTRODUCER SHEATH
EOQ
Bronchoscope (flexible Or Rigid)
309d
Cleared
Nov 18, 1997
ULTRACELL PACKING WITH SLEEVE
EMX
Balloon, Epistaxis
92d
Cleared
Nov 18, 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
EMX
Balloon, Epistaxis
54d
Cleared
Nov 06, 1997
INVOTEC EAR TAMPON (WICK) W/STRING
KCN
Ear Wick
48d
Cleared
Nov 05, 1997
POWERTREK INSTRUMENTS
ERL
Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
156d
Cleared
Nov 04, 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
ETD
Tube, Tympanostomy
69d
Cleared
Nov 04, 1997
MAGNATONE / STERLING/ ST
ESD
Hearing Aid, Air-conduction, Prescription
40d
Cleared
Nov 04, 1997
OTICON DIGISOUND ITE
ESD
Hearing Aid, Air-conduction, Prescription
21d
Cleared
Nov 04, 1997
OTICON DIGISOUND COMPACT
ESD
Hearing Aid, Air-conduction, Prescription
21d
Cleared
Nov 04, 1997
PERFECT EAR/ MINI-CANAL/ PE-M, PE-ML, PE-MD), PERFECT EAR/ C.I.C./ (PEC, PE-CD) (WITH OR WITHOUT RID-WAX BARRIER)
ESD
Hearing Aid, Air-conduction, Prescription
15d
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