510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K841511Substantially Equivalent

Haematuria Catheters

Warne Surgical Products, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K841511 is the FDA 510(k) clearance record for HAEMATURIA CATHETERS, a class II device, cleared for Warne Surgical Products, Ltd. on under FDA product code KOD (Catheter, Urological). FDA records list 15 510(k) clearances for Warne Surgical Products, Ltd., from to . As of , FDA records show no recalls naming K841511.

Clearance record

Decision date
Received
(92 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Warne Surgical Products, Ltd. 4221 Richmond Rd., NW, Walker MI
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