FFS · Class II · 21 CFR 876.1500

FDA Product Code FFS: Image, Illumination, Fiberoptic, For Endoscope

Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Smith & Nephew, Inc. and Cook Urological, Inc..

26
Total
26
Cleared
82d
Avg days
1984
Since

FDA 510(k) Cleared Image, Illumination, Fiberoptic, For Endoscope Devices (Product Code FFS)

26 devices
1–24 of 26
Cleared Nov 20, 2007
COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
K072521
Cook Urological, Inc.
Gastroenterology & Urology · 74d
Cleared Jan 20, 2000
SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES
K994084
Smith & Nephew, Inc.
Gastroenterology & Urology · 48d
Cleared Jul 06, 1999
SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR
K991323
Smith & Nephew, Inc.
Gastroenterology & Urology · 78d
Cleared Dec 23, 1998
SOLARTEC SOURCE 270, MODEL # 90123
K983714
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 63d
Cleared Sep 14, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K982462
Microvision, Inc.
Gastroenterology & Urology · 61d
Cleared May 20, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K980636
Dutch Ophthalmic USA, Inc.
Gastroenterology & Urology · 90d
Cleared Apr 02, 1997
VISTA ILLUMINATION SYSTEM
K970217
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 04, 1996
KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS
K962595
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 64d
Cleared Sep 09, 1993
KARL STORZ ENDOSCOPY-AMERICA, INC.
K933216
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 135d
Cleared Jul 28, 1989
FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
K893440
Welch Allyn, Inc.
Gastroenterology & Urology · 86d
Cleared May 08, 1989
LIGHT SOURCE, ENDOSCOP, XENON ARC
K890448
Mira, Inc.
Gastroenterology & Urology · 101d
Cleared Feb 21, 1984
FLEXIBLE LIQUID LIGHT GUIDE
K834487
Endo Lase, Inc.
Gastroenterology & Urology · 70d

About Product Code FFS - Regulatory Context