510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211032Substantially Equivalent

Urinary Catheter 12 Fr, Urinary Catheter 16 Fr

Urogen Pharma Ltd., Ra'Anana, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211032 is the FDA 510(k) clearance record for Urinary Catheter 12 Fr, Urinary Catheter 16 Fr, a class II device, cleared for Urogen Pharma, Ltd. on under FDA product code KOD (Catheter, Urological). FDA records list 5 510(k) clearances for Urogen Pharma, Ltd., from to . As of , FDA records show no recalls naming K211032.

Clearance record

Decision date
Received
(226 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Urogen Pharma, Ltd. 9 Ha'Ta'Asiya St., Ra'Anana, IL
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