FCS · Class II · 21 CFR 876.4020

FDA Product Code FCS: Light, Catheter, Fiberoptic, Glass, Ureteral

Leading manufacturers include Stryker Endoscopy, Stryker Corp. and Cook Urological, Inc..

10
Total
10
Cleared
152d
Avg days
1988
Since

FDA 510(k) Cleared Light, Catheter, Fiberoptic, Glass, Ureteral Devices (Product Code FCS)

10 devices
1–10 of 10
Cleared Aug 20, 2015
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
K151243
Stryker Endoscopy
Gastroenterology & Urology · 101d
Cleared Sep 28, 2006
STRYKER URETERAL ILLUMINATION SYSTEM IV
K061548
Stryker Corp.
Gastroenterology & Urology · 115d
Cleared Sep 22, 1998
STRYKER URETERAL ILLUMINATOR SYSTEM III
K982542
Stryker Endoscopy
Gastroenterology & Urology · 63d
Cleared Mar 05, 1993
ILLUMINATED URETERAL CATHETER
K923436
Cook Urological, Inc.
Gastroenterology & Urology · 235d

About Product Code FCS - Regulatory Context