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 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 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 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 Aug 27, 1985
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951
Welch Allyn, Inc.
Gastroenterology & Urology · 47d
Cleared Oct 19, 1983
PEDIATRIC ILLUMINATING URETERAL
K832807
Van-Tec, Inc.
Gastroenterology & Urology · 62d
Cleared Sep 30, 1977
PENTAX LH-150F LIGHT SOURCE
K771739
Pilling Co.
Gastroenterology & Urology · 15d
Cleared Dec 06, 1976
ADAPTER, FIBER OPTICS HEADLIGHT
K760647
Pilling Co.
Gastroenterology & Urology · 82d
Cleared Aug 30, 1976
FLOORSTAND, FIBER OPTIC LIGHT SOURCE
K760176
V. Mueller O.V. Baxter Healthcare Corp.
Gastroenterology & Urology · 55d

About Product Code FCW - Regulatory Context