Atlas FDA

EQH

49 FDA 510(k) clearances · Product code

71 daysmedian time to decision
250 days90th percentile
49clearances measured

FDA profile

Official device name
Source, Carrier, Fiberoptic Light
Device class
Class I (low risk)
Regulation
21 CFR 874.4350
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
1997: 3 · 1998: 1 · 2000: 2 · 2003: 1 · 2004: 4 · 2008: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (K945876)Wells Johnson Co.1995-12-04
JED-LIGHT FIBEROPTIC LIGHT SOURCE (K954184)Jedmed Instrument Co.1995-11-13
COLD LIGHT SOURCE LOS 150 (K951829)Laser-Optik-Systeme GmbH & Co. KG1995-07-10
BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (K932771)Xomed-Treace, Inc.1994-08-24
GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (K941661)Gm Engineering, Inc.1994-08-23
GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (K941662)Gm Engineering, Inc.1994-07-20
SAPHIRE PLUS SURGICAL MIRROR (K934911)San Diego Swiss Machining, Inc.1994-06-21
MID LABS TWIN ILLUMINATOR (K932131)Medical Instrument Development Laboratories, Inc.1994-04-01
ASPIRATING ENDO OCULAR PROBE (K930123)Surgical Technologies, Inc.1994-02-16
FIBEROPTIC LIGHTSOURCES AND CARRIERS (K933145)Electro Fiberoptics Corp.1993-09-07
THROAT-A-SCOPE (K923227)Truphatek, Ltd.1992-12-04
DISPOSABLE ENDOILLUMINATOR (K923774)O.R. Specialties, Inc.1992-10-19
LX 150 LIGHT SOURCE (K922095)Welch Allyn, Inc.1992-07-17
GRIESHABER THREE FUNCTION MANIPULATOR (K914586)Grieshaber & Co.1992-01-03
GRIESHABER TWO FUNCTION MANIPULATOR (K914585)Grieshaber & Co.1992-01-03
ASPIRATING ENDO OCULAR PROBE (K914247)Surgical Technologies, Inc.1991-12-18
KAPS 90 DEGREE FIBEROPTIC ADAPTOR (K912885)Jedmed Instrument Co.1991-08-30
FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC (K912767)Microaire Advanced Surgical Products1991-08-13
OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER (K912522)Summit Technology, Inc.1991-07-25
RIVER MEDICAL MICRODRILL SYSTEM (K905437)River Medical, Inc.1991-05-30
F.T.I. MEDICAL LIGHT GUIDE (K904378)Fiberoptics Technology, Inc.1991-01-16
SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE (K904470)Summit Technology, Inc.1990-12-24
FIBER OPTIC LIGHT SOURCE (K902784)Trek Medical Products, Inc.1990-09-12
FIBEROPTIC LIGHT SOURCE, FOI-1A (K896384)Jedmed Instrument Co.1990-01-23
LUXTEC FIBEROPTIC CABLES (K864387)Luxtec Corp.1987-05-22
LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS (K864383)Luxtec Corp.1987-01-14
FRAZIER SUCTION TUBE (K864382)Luxtec Corp.1987-01-14
ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE (K854751)Aspen Laboratories, Inc.1986-02-28
BRIMFIELD FIBEROPTIC LIGHT SCOURCE (K841731)Brimfield Scientific Instruments1984-07-16
VENT TUBE FORCEPS (K831589)Treace Medical, Inc.1983-06-16
T-TUBE INSERTER (K831590)Treace Medical, Inc.1983-06-15
MCGEE 26GA. SUCTION TUBE (K823437)Treace Medical, Inc.1982-12-09
MICROSURGICAL GAUGE (K823436)Treace Medical, Inc.1982-12-09
LARYNGEAL SPATULAS (K822259)Kelleher Corp.1982-10-22
FIBEROPTIC LIGHT CARRIERS (K822282)Kelleher Corp.1982-08-30
ADAPTOR FOR FIBEROPTIC LIGHT SOURCE (K822175)Kelleher Corp.1982-08-20
FIBEROPTIC LIGHT CARRIERS (K822192)Kelleher Corp.1982-08-20
NASAL INSTRUMENTS (K820621)Applied Fiberoptics, Inc.1982-03-19
DALE COMBO TRACHEOSTOMY TUBE HOLDER (K812429)Dale Medical Products, Inc.1981-09-23
FIBER OPTIC ADAPTER #60-0892 (K802774)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0894 (K802772)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-895 (K802771)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER CAT#60-0898 (K802766)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT GUIDE #60-0767 (K802773)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT GUIDE CAT#60-0768 (K802767)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0897 (K802768)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC ADAPTER #60-0896 (K802775)Aspen Laboratories, Inc.1980-12-16
FIBER OPTIC LIGHT SOURCE (K801176)Aspen Laboratories, Inc.1980-05-28
ADAPTER/STANDARD FIBER OPTICS LIGHT (K760653)Pilling Co.1976-12-06

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