Panels › Gastroenterology, Urology › Product code FCW · Class 2
Light Source, Fiberoptic, Routine
Regulation 876.1500
0510(k)s in 12 months (31 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in FCW
| Company | 510(k)s | Recalls |
|---|---|---|
| Integra LifeSciences Corp. | 0 | 4 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Luxtec Corp. | 2 | 0 |
| Pilling Co. | 2 | 0 |
| Stryker Corp. | 1 | 1 |
| Welch Allyn, Inc. | 2 | 0 |
| Acueity, Inc. | 1 | 0 |
| Angiolaz, Inc. | 1 | 0 |
| Circon Video | 1 | 0 |
| Corin USA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2014 | K131226 | NOVAPROBE LED LIGHT SOURCE Novaprobe Incorporated | FCW |
| Jan 25, 2013 | K123956 | POWER LED 175 KARL STORZ Endoscopy-America, Inc. | FCW |
| Dec 19, 2012 | K123359 | OVS1 VIDEO SYSTEM Olive Medical Corp. | FCW |
| Sep 20, 2012 | K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 Richard Wolf Medical Instruments Corp. | FCW |
| Mar 18, 2010 | K093792 | LED LIGHT SOURCE Sunoptic Technologies, LLC | FCW |
| Sep 14, 2009 | K091968 | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C KARL STORZ Endoscopy-America, Inc. | FCW |
| Dec 19, 2008 | K082813 | STRYKER LED LIGHTSOURCE Stryker Corp. | FCW |
| Jun 18, 2008 | K081477 | LUXTEC MLX LIGHT SOURCE Integra Luxtec, Inc. | FCW |
| Sep 5, 2003 | K032430 | ACUEITY MEDICAL LIGHT SOURCE Acueity, Inc. | FCW |
| Oct 17, 2001 | K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 Circon Video | FCW |
| Mar 21, 2000 | K000229 | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE Videolabs, Inc. | FCW |
| Nov 5, 1999 | K993300 | COLDLIGHTSOURCE PL3000 Fiber Imaging Technologies, Inc. | FCW |
| Oct 20, 1999 | K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. Angiolaz, Inc. | FCW |
| Mar 12, 1997 | K970598 | INTEGRATED VISUALIZATION SYSTEM Urohealth, Inc. | FCW |
| Jan 17, 1997 | K964586 | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 Iba/Griffith | FCW |
| Sep 20, 1996 | K963043 | ENDOSPOT Corin USA | FCW |
| May 17, 1995 | K951647 | WELCH ALLYN HI - LUX ILLUMINATOR Welch Allyn, Inc. | FCW |
| Dec 8, 1994 | K945420 | CHAKOFF ENDOSCOPY Stephen Chakoff, Inc. | FCW |
| Jul 1, 1994 | K942155 | HMT ENDOSCREEN, MODEL ESC 501 Servicetrends, Inc. | FCW |
| May 18, 1994 | K934531 | AUTO SUTURE DISPOSABLE LIGHT CABLE United States Surgical, A Division of Tyco Healthc | FCW |
| Jan 3, 1994 | K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES Cuda Products Co. | FCW |
| Jan 23, 1991 | K905376 | STORZ S6000 LIGHT SOURCE Storz Instrument Co. | FCW |
| Dec 7, 1990 | K903790 | ENDOSCOPIC LIGHT SOURCE 250 ENDO Orlux Engineering and Instrumentation, CA | FCW |
| Apr 26, 1989 | K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE Luxtec Corp. | FCW |
| Jan 13, 1987 | K864385 | LUXTEC LIGHT SOURCES Luxtec Corp. | FCW |
| Aug 27, 1985 | K852951 | WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS Welch Allyn, Inc. | FCW |
| Aug 9, 1984 | K842609 | R.L. MEDICAL TWIN LIGHT SOURCE Tridak Division of Indicon, Inc. | FCW |
| Oct 19, 1983 | K832807 | PEDIATRIC ILLUMINATING URETERAL Van-Tec, Inc. | FCW |
| Sep 30, 1977 | K771739 | PENTAX LH-150F LIGHT SOURCE Pilling Co. | FCW |
| Dec 6, 1976 | K760647 | ADAPTER, FIBER OPTICS HEADLIGHT Pilling Co. | FCW |
| Aug 30, 1976 | K760176 | FLOORSTAND, FIBER OPTIC LIGHT SOURCE V. Mueller O.V. Baxter Healthcare Corp. | FCW |
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