Circon Endotek Om-4 H2O Cystometry Pump

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K970595 ↗

FDA Product Code

FEN

Device Class

Class II

Regulation

21 CFR Part 876.1620

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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