FDA Device Intelligence
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Light, Catheter, Fiberoptic, Glass, Ureteral

FDA product code FCS · Class 2 · Gastroenterology, Urology

10
Registered devices
93
Adverse events
3
Recalls
10
510(k) clearances

Devices with this code

Bush — COOK INCORPORATEDn.a. — Karl Storz GmbH & Co. KGBush — COOK INCORPORATEDBush — COOK INCORPORATEDn.a. — Karl Storz GmbH & Co. KGBush — COOK INCORPORATEDInfraVision — STRYKER CORPORATIONBush — COOK INCORPORATEDIRIS — STRYKER CORPORATIONBush — COOK INCORPORATED

Recent recalls

DateFirmReason
2017-03-07Cook Inc.Product may overheat, melt, and burn patient.
2008-05-09Stryker EndoscopyKit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery
2008-05-09Stryker EndoscopyKit fibers may not illuminate along entire length, which may result in inadequate visibility of the urethral structures during surgery

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.