Product Code: FCW FDA class 2 21 CFR 876.1500

Light Source, Fiberoptic, Routine

Gastroenterology, Urology

The Routine Fiberoptic Light Source (product code FCW) is a standard fiberoptic illumination unit used to provide light to endoscopes and other fiberoptic instruments during routine diagnostic and therapeutic procedures. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.1500 in the Gastroenterology and Urology specialty. No special flags apply.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: FCW
Device Class: FDA class 2
Regulation Number: 876.1500
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K131226	NOVAPROBE LED LIGHT SOURCE	Jul 24, 2014	Substantially Equivalent	Novaprobe Incorporated
K123956	POWER LED 175	Jan 25, 2013	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K123359	OVS1 VIDEO SYSTEM	Dec 19, 2012	Substantially Equivalent	Olive Medical Corp.
K121724	ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2	Sep 20, 2012	Substantially Equivalent	Richard Wolf Medical Instruments Corp.
K093792	LED LIGHT SOURCE	Mar 18, 2010	Substantially Equivalent	Sunoptic Technologies, LLC
K091968	KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C	Sep 14, 2009	Substantially Equivalent	KARL STORZ Endoscopy-America, Inc.
K082813	STRYKER LED LIGHTSOURCE	Dec 19, 2008	Substantially Equivalent	Stryker Corp.
K081477	LUXTEC MLX LIGHT SOURCE	Jun 18, 2008	Substantially Equivalent	Integra Luxtec, Inc.
K032430	ACUEITY MEDICAL LIGHT SOURCE	Sep 05, 2003	Substantially Equivalent	Acueity, Inc.
K012265	METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088	Oct 17, 2001	Substantially Equivalent	Circon Video
K000229	VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE	Mar 21, 2000	Substantially Equivalent	Videolabs, Inc.
K993300	COLDLIGHTSOURCE PL3000	Nov 05, 1999	Substantially Equivalent	Fiber Imaging Technologies, Inc.
K992447	50 W METAL HALIDE ILLUMINATOR, VES 0501.	Oct 20, 1999	Substantially Equivalent	Angiolaz, Inc.
K970598	INTEGRATED VISUALIZATION SYSTEM	Mar 12, 1997	Substantially Equivalent	Urohealth, Inc.
K964586	PRESCOTT'S LIGHT SOURCE MODEL NO. II-150	Jan 17, 1997	Substantially Equivalent	Iba/Griffith
K963043	ENDOSPOT	Sep 20, 1996	Substantially Equivalent	Corin USA
K951647	WELCH ALLYN HI - LUX ILLUMINATOR	May 17, 1995	Substantially Equivalent	Welch Allyn, Inc.
K945420	CHAKOFF ENDOSCOPY	Dec 08, 1994	Substantially Equivalent	Stephen Chakoff, Inc.
K942155	HMT ENDOSCREEN, MODEL ESC 501	Jul 01, 1994	Substantially Equivalent	Servicetrends, Inc.
K934531	AUTO SUTURE DISPOSABLE LIGHT CABLE	May 18, 1994	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K933369	CUDA PRODUCTS CORP. LIGHTSOURCES	Jan 03, 1994	Substantially Equivalent	Cuda Products Co.
K905376	STORZ S6000 LIGHT SOURCE	Jan 23, 1991	Substantially Equivalent	Storz Instrument Co.
K903790	ENDOSCOPIC LIGHT SOURCE 250 ENDO	Dec 07, 1990	Substantially Equivalent	Orlux Engineering and Instrumentation
K890716	LUXTEC ACO SERIES 4000 LIGHT SOURCE	Apr 26, 1989	Substantially Equivalent	Luxtec Corp.
K864385	LUXTEC LIGHT SOURCES	Jan 13, 1987	Substantially Equivalent	Luxtec Corp.
K852951	WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS	Aug 27, 1985	Substantially Equivalent	Welch Allyn, Inc.
K842609	R.L. MEDICAL TWIN LIGHT SOURCE	Aug 09, 1984	Substantially Equivalent	Tridak Division of Indicon, Inc.
K832807	PEDIATRIC ILLUMINATING URETERAL	Oct 19, 1983	Substantially Equivalent	Van-Tec, Inc.
K771739	PENTAX LH-150F LIGHT SOURCE	Sep 30, 1977	Substantially Equivalent	Pilling Co.
K760647	ADAPTER, FIBER OPTICS HEADLIGHT	Dec 06, 1976	Substantially Equivalent	Pilling Co.
K760176	FLOORSTAND, FIBER OPTIC LIGHT SOURCE	Aug 30, 1976	Substantially Equivalent	V. Mueller O.V. Baxter Healthcare Corp.