Product code FCW
- Device name
- Light Source, Fiberoptic, Routine
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131226 | NOVAPROBE LED LIGHT SOURCE | Novaprobe Incorporated | 2014-07-24 |
| K123956 | POWER LED 175 | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
| K123359 | OVS1 VIDEO SYSTEM | Olive Medical Corp. | 2012-12-19 |
| K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| K093792 | LED LIGHT SOURCE | Sunoptic Technologies, LLC | 2010-03-18 |
| K091968 | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C | KARL STORZ Endoscopy-America, Inc. | 2009-09-14 |
| K082813 | STRYKER LED LIGHTSOURCE | Stryker Corp. | 2008-12-19 |
| K081477 | LUXTEC MLX LIGHT SOURCE | Integra Luxtec, Inc. | 2008-06-18 |
| K032430 | ACUEITY MEDICAL LIGHT SOURCE | Acueity, Inc. | 2003-09-05 |
| K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | Circon Video | 2001-10-17 |
| K000229 | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE | Videolabs, Inc. | 2000-03-21 |
| K993300 | COLDLIGHTSOURCE PL3000 | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | Angiolaz, Inc. | 1999-10-20 |
| K970598 | INTEGRATED VISUALIZATION SYSTEM | Urohealth, Inc. | 1997-03-12 |
| K964586 | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 | Iba/Griffith | 1997-01-17 |
| K963043 | ENDOSPOT | Corin USA | 1996-09-20 |
| K951647 | WELCH ALLYN HI - LUX ILLUMINATOR | Welch Allyn, Inc. | 1995-05-17 |
| K945420 | CHAKOFF ENDOSCOPY | Stephen Chakoff, Inc. | 1994-12-08 |
| K942155 | HMT ENDOSCREEN, MODEL ESC 501 | Servicetrends, Inc. | 1994-07-01 |
| K934531 | AUTO SUTURE DISPOSABLE LIGHT CABLE | United States Surgical, A Division of Tyco Healthc | 1994-05-18 |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | Cuda Products Co. | 1994-01-03 |
| K905376 | STORZ S6000 LIGHT SOURCE | Storz Instrument Co. | 1991-01-23 |
| K903790 | ENDOSCOPIC LIGHT SOURCE 250 ENDO | Orlux Engineering and Instrumentation | 1990-12-07 |
| K890716 | LUXTEC ACO SERIES 4000 LIGHT SOURCE | Luxtec Corp. | 1989-04-26 |
| K864385 | LUXTEC LIGHT SOURCES | Luxtec Corp. | 1987-01-13 |
| K852951 | WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS | Welch Allyn, Inc. | 1985-08-27 |
| K842609 | R.L. MEDICAL TWIN LIGHT SOURCE | Tridak Division of Indicon, Inc. | 1984-08-09 |
| K832807 | PEDIATRIC ILLUMINATING URETERAL | Van-Tec, Inc. | 1983-10-19 |
| K771739 | PENTAX LH-150F LIGHT SOURCE | Pilling Co. | 1977-09-30 |
| K760647 | ADAPTER, FIBER OPTICS HEADLIGHT | Pilling Co. | 1976-12-06 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327174816 | IRIS | STRYKER CORPORATION | 2016-09-23 |
| 10381780168287 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168874 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168812 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168454 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168447 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168430 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168386 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168379 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168362 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168355 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168348 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168331 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168324 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168300 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168294 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168270 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168263 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168256 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168249 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168201 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168195 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168188 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168140 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168089 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168041 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780167969 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780167891 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780152712 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |
| 10381780152705 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-03 |