510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161344Substantially Equivalent

GentleCath Glide Intermittent Catheter

ConvaTec Limited, Deeside, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161344 is the FDA 510(k) clearance record for GentleCath Glide Intermittent Catheter, a class II device, cleared for Convatec Limited on under FDA product code KOD (Catheter, Urological). FDA records list 29 510(k) clearances for Convatec Limited, from to . As of , FDA records show no recalls naming K161344.

Clearance record

Decision date
Received
(130 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Convatec Limited Gdc, First Ave., Deeside Industrial Park, Deeside, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KOD

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