Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath

• • Terminated Z-2540-2017 FDA Class II ·initiated 3 May 2017

  Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

510(k) Number

K072521 ↗

FDA Product Code

FFS

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Urological, Inc. →