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 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

About Product Code FFS - Regulatory Context