Argyle Silicone Salem Sump Tube

• • Ongoing Z-0208-2026 FDA Class II ·initiated 18 Sep 2025

  Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.

510(k) Number

K830710 ↗

FDA Product Code

KNT

Device Class

Class II

Regulation

21 CFR Part 876.5980

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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See all devices from Sherwood Medical Co. →