FCS · Class II · 21 CFR 876.4020

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

Leading manufacturers include Stryker Endoscopy, Gabriel Medical, Inc. and Stryker Corp..

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 Aug 15, 1995
URIGLOW TRANSILLUMINATING URETERIC STENT MODEL
K943801
Rocket of London, Ltd.
Gastroenterology & Urology · 377d
Cleared Feb 07, 1995
GABRIEL URETERAL ILLUMINATOR SYSTEM II
K945088
Gabriel Medical, Inc.
Gastroenterology & Urology · 113d
Cleared Oct 05, 1994
URETERAL ILLUMINATOR
K941506
Apple Medical Corp.
Gastroenterology & Urology · 190d
Cleared May 02, 1994
GABRIEL URETERAL ILLUMINATOR SYSTEM
K940019
Gabriel Medical, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 05, 1993
ILLUMINATED URETERAL CATHETER
K923436
Cook Urological, Inc.
Gastroenterology & Urology · 235d
Cleared Mar 23, 1988
LASEGUIDE 600A, 600B, 400A, AND 400B
K874680
Laser Peripherals, LLC
Gastroenterology & Urology · 131d
Cleared Mar 22, 1988
SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE
K880071
Laserguide
Gastroenterology & Urology · 71d

About Product Code FCS - Regulatory Context