FFS — Image, Illumination, Fiberoptic, For Endoscope Class II
FDA product code FFS covers "Image, Illumination, Fiberoptic, For Endoscope", 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
- FFS
- 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 |
|---|---|---|---|
| K072521 | cook urological | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | November 20, 2007 |
| K061622 | photonic optische gerate gesmbh and cokg | PS SERIES | March 5, 2007 |
| K063309 | truphatek international | TRU-CABLE | January 12, 2007 |
| K061025 | accutech medical technologies | ACCUTECH ENDOLITE PROBE | May 31, 2006 |
| K023633 | sovis optique | SOVIS OPTIQUE'S ENDOSCOPIC CABLE | December 31, 2002 |
| K001698 | cogent light technologies | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 | July 17, 2000 |
| K994084 | smith and nephew | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES | January 20, 2000 |
| K991323 | smith and nephew | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR | July 6, 1999 |
| K983714 | cogent light technologies | SOLARTEC SOURCE 270, MODEL # 90123 | December 23, 1998 |
| K982462 | microvision | FIBER OPTIC ENDOILLUMINATION PROBE | September 14, 1998 |
| K980636 | dutch ophthalmic usa | FIBER OPTIC ENDOILLUMINATION PROBE | May 20, 1998 |
| K970217 | vista medical technologies | VISTA ILLUMINATION SYSTEM | April 2, 1997 |
| K962595 | karl storz endoscopy-america | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS | September 4, 1996 |
| K950960 | luxtec | REDDY ILLUMINATOR | September 8, 1995 |
| K945102 | alm surgical equipment | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE | November 4, 1994 |
| K944688 | progressive dynamics | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR | November 1, 1994 |
| K940962 | incredivision | LIQUID LIGHT 500 | April 8, 1994 |
| K940963 | incredivision | XENON LIGHT SOURCE | April 8, 1994 |
| K933216 | karl storz endoscopy-america | KARL STORZ ENDOSCOPY-AMERICA, INC. | September 9, 1993 |
| K892145 | opto vision | FIBER OPTIC LIGHT TRANSMISSION CABLE | September 29, 1989 |