510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260919Substantially Equivalent

Transurethral Catheter Safety Valve (TUCSV) (80050)

Class Medical, Ltd., Co Limerick, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260919 is the FDA 510(k) clearance record for Transurethral Catheter Safety Valve (TUCSV) (80050), a class II device, cleared for Class Medical , Ltd. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list one 510(k) clearance for Class Medical , Ltd. As of , FDA records show no recalls naming K260919.

Clearance record

Decision date
Received
(139 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Class Medical , Ltd. Unit 1d Annacotty Business Park, Co Limerick, IE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KNY

Trailing 12 months
1 clearance under product code KNY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260