FCW · Class II · 21 CFR 876.1500

FDA Product Code FCW: Light Source, Fiberoptic, Routine

Leading manufacturers include KARL STORZ Endoscopy-America, Inc. and United States Surgical, A Division of Tyco Healthc.

31
Total
31
Cleared
80d
Avg days
1976
Since

FDA 510(k) Cleared Light Source, Fiberoptic, Routine Devices (Product Code FCW)

31 devices
1–24 of 31
Cleared Jan 25, 2013
POWER LED 175
K123956
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 35d
Cleared Sep 14, 2009
KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
K091968
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared May 18, 1994
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531
United States Surgical, A Division of Tyco Healthc
Gastroenterology & Urology · 240d

About Product Code FCW - Regulatory Context