Panels › Gastroenterology, Urology › Product code FFS · Class 2
Image, Illumination, Fiberoptic, For Endoscope
Regulation 876.1500
0510(k)s in 12 months (26 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Cogent Light Technologies, Inc. | 2 | 0 |
| Incredivision, Inc. | 2 | 0 |
| KARL STORZ Endoscopy-America, Inc. | 2 | 0 |
| Smith & Nephew, Inc. | 2 | 0 |
| Accutech Medical Technologies, Inc. | 1 | 0 |
| Alm Surgical Equipment, Inc. | 1 | 0 |
| Cook Inc. | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Douglas Manufacturer Co. | 1 | 0 |
| Dutch Ophthalmic USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 20, 2007 | K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH Cook Urological, Inc. | FFS |
| Mar 5, 2007 | K061622 | PS SERIES Photonic Optische Gerate Gesmbh & Cokg, AT | FFS |
| Jan 12, 2007 | K063309 | TRU-CABLE Truphatek International, Ltd. | FFS |
| May 31, 2006 | K061025 | ACCUTECH ENDOLITE PROBE Accutech Medical Technologies, Inc. | FFS |
| Dec 31, 2002 | K023633 | SOVIS OPTIQUE'S ENDOSCOPIC CABLE Sovis Optique | FFS |
| Jul 17, 2000 | K001698 | MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 Cogent Light Technologies, Inc. | FFS |
| Jan 20, 2000 | K994084 | SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES Smith & Nephew, Inc. | FFS |
| Jul 6, 1999 | K991323 | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR Smith & Nephew, Inc. | FFS |
| Dec 23, 1998 | K983714 | SOLARTEC SOURCE 270, MODEL # 90123 Cogent Light Technologies, Inc. | FFS |
| Sep 14, 1998 | K982462 | FIBER OPTIC ENDOILLUMINATION PROBE Microvision, Inc. | FFS |
| May 20, 1998 | K980636 | FIBER OPTIC ENDOILLUMINATION PROBE Dutch Ophthalmic USA, Inc. | FFS |
| Apr 2, 1997 | K970217 | VISTA ILLUMINATION SYSTEM Vista Medical Technologies, Inc. | FFS |
| Sep 4, 1996 | K962595 | KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS KARL STORZ Endoscopy-America, Inc. | FFS |
| Sep 8, 1995 | K950960 | REDDY ILLUMINATOR Luxtec Corp. | FFS |
| Nov 4, 1994 | K945102 | MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE Alm Surgical Equipment, Inc. | FFS |
| Nov 1, 1994 | K944688 | LUMINOUS 150 DUAL LAMPFIBEROPTIC ILLUMINATOR Progressive Dynamics, Inc. | FFS |
| Apr 8, 1994 | K940963 | XENON LIGHT SOURCE Incredivision, Inc. | FFS |
| Apr 8, 1994 | K940962 | LIQUID LIGHT 500 Incredivision, Inc. | FFS |
| Sep 9, 1993 | K933216 | KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ Endoscopy-America, Inc. | FFS |
| Sep 29, 1989 | K892145 | FIBER OPTIC LIGHT TRANSMISSION CABLE Opto Vision, Inc. | FFS |
| Jul 28, 1989 | K893440 | FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150 Welch Allyn, Inc. | FFS |
| May 8, 1989 | K890448 | LIGHT SOURCE, ENDOSCOP, XENON ARC Mira, Inc. | FFS |
| Jan 8, 1985 | K844773 | EFF-EFFNER BULBS Mecron Medical Products, Inc. | FFS |
| Apr 20, 1984 | K834576 | REAL FIBER OPTIC URETERAL TRANSILLUMIN Douglas Manufacturer Co. | FFS |
| Apr 13, 1984 | K840605 | LABORIE FIBREOPTIC LIGHT CABLE Tridak Division of Indicon, Inc. | FFS |
| Feb 21, 1984 | K834487 | FLEXIBLE LIQUID LIGHT GUIDE Endo Lase, Inc. | FFS |
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