FCW — Light Source, Fiberoptic, Routine Class II
FDA product code FCW covers "Light Source, Fiberoptic, Routine", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FCW
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131226 | novaprobe incorporated | NOVAPROBE LED LIGHT SOURCE | July 24, 2014 |
| K123956 | karl storz endoscopy-america | POWER LED 175 | January 25, 2013 |
| K123359 | olive medical | OVS1 VIDEO SYSTEM | December 19, 2012 |
| K121724 | richard wolf medical instruments | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | September 20, 2012 |
| K093792 | sunoptic technologies | LED LIGHT SOURCE | March 18, 2010 |
| K091968 | karl storz endoscopy-america | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C | September 14, 2009 |
| K082813 | stryker | STRYKER LED LIGHTSOURCE | December 19, 2008 |
| K081477 | integra luxtec | LUXTEC MLX LIGHT SOURCE | June 18, 2008 |
| K032430 | acueity | ACUEITY MEDICAL LIGHT SOURCE | September 5, 2003 |
| K012265 | circon video | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | October 17, 2001 |
| K000229 | videolabs | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE | March 21, 2000 |
| K993300 | fiber imaging technologies | COLDLIGHTSOURCE PL3000 | November 5, 1999 |
| K992447 | angiolaz | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | October 20, 1999 |
| K970598 | urohealth | INTEGRATED VISUALIZATION SYSTEM | March 12, 1997 |
| K964586 | iba/griffith | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 | January 17, 1997 |
| K963043 | corin usa | ENDOSPOT | September 20, 1996 |
| K951647 | welch allyn | WELCH ALLYN HI - LUX ILLUMINATOR | May 17, 1995 |
| K945420 | stephen chakoff | CHAKOFF ENDOSCOPY | December 8, 1994 |
| K942155 | servicetrends | HMT ENDOSCREEN, MODEL ESC 501 | July 1, 1994 |
| K934531 | united states surgical, a division of tyco healthc | AUTO SUTURE DISPOSABLE LIGHT CABLE | May 18, 1994 |