FCW · Class II · 21 CFR 876.1500

FDA Product Code FCW: Light Source, Fiberoptic, Routine

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Pilling Co. and Welch Allyn, Inc..

31
Total
31
Cleared
80d
Avg days
1976
Since

FDA 510(k) Cleared Light Source, Fiberoptic, Routine Devices (Product Code FCW)

31 devices
1–24 of 31
Cleared Jul 24, 2014
NOVAPROBE LED LIGHT SOURCE
K131226
Novaprobe Incorporated
Gastroenterology & Urology · 450d
Cleared Jan 25, 2013
POWER LED 175
K123956
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 35d
Cleared Dec 19, 2012
OVS1 VIDEO SYSTEM
K123359
Olive Medical Corp.
Gastroenterology & Urology · 49d
Cleared Sep 20, 2012
ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2
K121724
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 100d
Cleared Mar 18, 2010
LED LIGHT SOURCE
K093792
Sunoptic Technologies, LLC
Gastroenterology & Urology · 98d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Dec 19, 2008
STRYKER LED LIGHTSOURCE
K082813
Stryker Corp.
Gastroenterology & Urology · 86d
Cleared Jun 18, 2008
LUXTEC MLX LIGHT SOURCE
K081477
Integra Luxtec, Inc.
Gastroenterology & Urology · 22d
Cleared Sep 05, 2003
ACUEITY MEDICAL LIGHT SOURCE
K032430
Acueity, Inc.
Gastroenterology & Urology · 30d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265
Circon Video
Gastroenterology & Urology · 90d
Cleared Mar 21, 2000
VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE
K000229
Videolabs, Inc.
Gastroenterology & Urology · 54d
Cleared Nov 05, 1999
COLDLIGHTSOURCE PL3000
K993300
Fiber Imaging Technologies, Inc.
Gastroenterology & Urology · 35d
Cleared Oct 20, 1999
50 W METAL HALIDE ILLUMINATOR, VES 0501.
K992447
Angiolaz, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 12, 1997
INTEGRATED VISUALIZATION SYSTEM
K970598
Urohealth, Inc.
Gastroenterology & Urology · 22d
Cleared Jan 17, 1997
PRESCOTT'S LIGHT SOURCE MODEL NO. II-150
K964586
Iba/Griffith
Gastroenterology & Urology · 63d
Cleared Sep 20, 1996
ENDOSPOT
K963043
Corin USA
Gastroenterology & Urology · 46d
Cleared May 17, 1995
WELCH ALLYN HI - LUX ILLUMINATOR
K951647
Welch Allyn, Inc.
Gastroenterology & Urology · 37d
Cleared Dec 08, 1994
CHAKOFF ENDOSCOPY
K945420
Stephen Chakoff, Inc.
Gastroenterology & Urology · 34d
Cleared Jul 01, 1994
HMT ENDOSCREEN, MODEL ESC 501
K942155
Servicetrends, Inc.
Gastroenterology & Urology · 59d
Cleared May 18, 1994
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 240d
Cleared Jan 03, 1994
CUDA PRODUCTS CORP. LIGHTSOURCES
K933369
Cuda Products Co.
Gastroenterology & Urology · 178d
Cleared Jan 23, 1991
STORZ S6000 LIGHT SOURCE
K905376
Storz Instrument Co.
Gastroenterology & Urology · 54d
Cleared Dec 07, 1990
ENDOSCOPIC LIGHT SOURCE 250 ENDO
K903790
Orlux Engineering and Instrumentation
Gastroenterology & Urology · 109d
Cleared Apr 26, 1989
LUXTEC ACO SERIES 4000 LIGHT SOURCE
K890716
Luxtec Corp.
Gastroenterology & Urology · 72d

About Product Code FCW - Regulatory Context