Product Code: EQH FDA class 1 21 CFR 874.4350

Source, Carrier, Fiberoptic Light

Ear, Nose, Throat

The fiberoptic light source and carrier is a device that generates and transmits light via fiber optic cables to illuminate body cavities during ENT surgical or diagnostic procedures. It is classified as FDA Class 1, indicating low risk and requiring only general controls without a premarket notification. The product code is EQH, regulated under 21 CFR 874.4350 in the Ear, Nose, Throat specialty. No special regulatory flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: EQH
Device Class: FDA class 1
Regulation Number: 874.4350
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K945876	WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT	Dec 04, 1995	Substantially Equivalent	Wells Johnson Co.
K954184	JED-LIGHT FIBEROPTIC LIGHT SOURCE	Nov 13, 1995	Substantially Equivalent	Jedmed Instrument Co.
K951829	COLD LIGHT SOURCE LOS 150	Jul 10, 1995	Substantially Equivalent	Laser-Optik-Systeme GmbH & Co. KG
K932771	BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE	Aug 24, 1994	Substantially Equivalent	Xomed-Treace, Inc.
K941661	GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT	Aug 23, 1994	Substantially Equivalent	Gm Engineering, Inc.
K941662	GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT	Jul 20, 1994	Substantially Equivalent	Gm Engineering, Inc.
K934911	SAPHIRE PLUS SURGICAL MIRROR	Jun 21, 1994	Substantially Equivalent	San Diego Swiss Machining, Inc.
K932131	MID LABS TWIN ILLUMINATOR	Apr 01, 1994	Substantially Equivalent	Medical Instrument Development Laboratories, Inc.
K930123	ASPIRATING ENDO OCULAR PROBE	Feb 16, 1994	Substantially Equivalent	Surgical Technologies, Inc.
K933145	FIBEROPTIC LIGHTSOURCES AND CARRIERS	Sep 07, 1993	Substantially Equivalent	Electro Fiberoptics Corp.
K923227	THROAT-A-SCOPE	Dec 04, 1992	Substantially Equivalent	Truphatek, Ltd.
K923774	DISPOSABLE ENDOILLUMINATOR	Oct 19, 1992	Substantially Equivalent	O.R. Specialties, Inc.
K922095	LX 150 LIGHT SOURCE	Jul 17, 1992	Substantially Equivalent	Welch Allyn, Inc.
K914586	GRIESHABER THREE FUNCTION MANIPULATOR	Jan 03, 1992	Substantially Equivalent	Grieshaber & Co.
K914585	GRIESHABER TWO FUNCTION MANIPULATOR	Jan 03, 1992	Substantially Equivalent	Grieshaber & Co.
K914247	ASPIRATING ENDO OCULAR PROBE	Dec 18, 1991	Substantially Equivalent	Surgical Technologies, Inc.
K912885	KAPS 90 DEGREE FIBEROPTIC ADAPTOR	Aug 30, 1991	Substantially Equivalent	Jedmed Instrument Co.
K912767	FIBER OPTIC UNIVERAL CABLES, SCOPE ADAP., LT.SOURC	Aug 13, 1991	Substantially Equivalent	Microaire Advanced Surgical Products
K912522	OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER	Jul 25, 1991	Substantially Equivalent	Summit Technology, Inc.
K905437	RIVER MEDICAL MICRODRILL SYSTEM	May 30, 1991	Substantially Equivalent	River Medical, Inc.
K904378	F.T.I. MEDICAL LIGHT GUIDE	Jan 16, 1991	Substantially Equivalent	Fiberoptics Technology, Inc.
K904470	SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE	Dec 24, 1990	Substantially Equivalent	Summit Technology, Inc.
K902784	FIBER OPTIC LIGHT SOURCE	Sep 12, 1990	Substantially Equivalent	Trek Medical Products, Inc.
K896384	FIBEROPTIC LIGHT SOURCE, FOI-1A	Jan 23, 1990	Substantially Equivalent	Jedmed Instrument Co.
K864387	LUXTEC FIBEROPTIC CABLES	May 22, 1987	Substantially Equivalent	Luxtec Corp.
K864383	LUXTEC, KILLIAN AND VIENNA NASAL SPECULUMS	Jan 14, 1987	Substantially Equivalent	Luxtec Corp.
K864382	FRAZIER SUCTION TUBE	Jan 14, 1987	Substantially Equivalent	Luxtec Corp.
K854751	ZIMMER VIDEO PRODUCTS AUTOMATIC LIGHT SOURCE	Feb 28, 1986	Substantially Equivalent	Aspen Laboratories, Inc.
K841731	BRIMFIELD FIBEROPTIC LIGHT SCOURCE	Jul 16, 1984	Substantially Equivalent	Brimfield Scientific Instruments
K831589	VENT TUBE FORCEPS	Jun 16, 1983	Substantially Equivalent	Treace Medical, Inc.
K831590	T-TUBE INSERTER	Jun 15, 1983	Substantially Equivalent	Treace Medical, Inc.
K823437	MCGEE 26GA. SUCTION TUBE	Dec 09, 1982	Substantially Equivalent	Treace Medical, Inc.
K823436	MICROSURGICAL GAUGE	Dec 09, 1982	Substantially Equivalent	Treace Medical, Inc.
K822259	LARYNGEAL SPATULAS	Oct 22, 1982	Substantially Equivalent	Kelleher Corp.
K822282	FIBEROPTIC LIGHT CARRIERS	Aug 30, 1982	Substantially Equivalent	Kelleher Corp.
K822192	FIBEROPTIC LIGHT CARRIERS	Aug 20, 1982	Substantially Equivalent	Kelleher Corp.
K822175	ADAPTOR FOR FIBEROPTIC LIGHT SOURCE	Aug 20, 1982	Substantially Equivalent	Kelleher Corp.
K820621	NASAL INSTRUMENTS	Mar 19, 1982	Substantially Equivalent	Applied Fiberoptics, Inc.
K812429	DALE COMBO TRACHEOSTOMY TUBE HOLDER	Sep 23, 1981	Substantially Equivalent	Dale Medical Products, Inc.
K802775	FIBER OPTIC ADAPTER #60-0896	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802774	FIBER OPTIC ADAPTER #60-0892	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802773	FIBER OPTIC LIGHT GUIDE #60-0767	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802772	FIBER OPTIC ADAPTER #60-0894	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802771	FIBER OPTIC ADAPTER #60-895	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802768	FIBER OPTIC ADAPTER #60-0897	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802767	FIBER OPTIC LIGHT GUIDE CAT#60-0768	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K802766	FIBER OPTIC ADAPTER CAT#60-0898	Dec 16, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K801176	FIBER OPTIC LIGHT SOURCE	May 28, 1980	Substantially Equivalent	Aspen Laboratories, Inc.
K760653	ADAPTER/STANDARD FIBER OPTICS LIGHT	Dec 06, 1976	Substantially Equivalent	Pilling Co.