Transurethral Catheter Safety Valve (TUCSV) (80050)— 510(k) K260919

Name: FDA 510(k) clearance K260919
Creator: U.S. Food and Drug Administration
Published: 2026-08-05

Substantially Equivalent

Class Medical , Ltd.

FDA 510(k) clearance K260919 for Transurethral Catheter Safety Valve (TUCSV) (80050), Substantially Equivalent on 2026-08-05. Applicant: Class Medical , Ltd.. Device class: 2.

Summary

Class Medical filed the Transurethral Catheter Safety Valve (TUCSV), listed as 80050, under product code KNY, G-U catheter accessories.

Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).

Class Medical filed from Co Limerick, Ireland. Review took 139 calendar days (March 19 to August 5, 2026) and ended in a substantially equivalent decision.

Clearance details

Applicant: Class Medical , Ltd.
Product code: Product code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-19
Decision date: 2026-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Co Limerick, IE

Download summary PDF View on FDA.gov ↗

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K140562 — WIJAY EZ-VOID EXTERNAL CATHETER VALVE2014-06-16
K141252 — GUARDIAN URETHRAL SHEATH2014-06-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.