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.

Clearance details

Applicant: Class Medical , Ltd.
Product code: 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.