Evis Exera Colonovideoscope Cf-Q160 Al/I and Pcf-160 Al/I

• • Ongoing Z-0329-2024 FDA Class II ·initiated 25 Sep 2023 ·on shared 510(k) K001241

  Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K001241 ↗

FDA Product Code

FDF

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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