510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K903777Substantially Equivalent

Wrp Foleycath

Wembley Rubber Products (M) Sdn Bhd, Selangor, Malaysia, MY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903777 is the FDA 510(k) clearance record for WRP FOLEYCATH, a class II device, cleared for Wembley Rubber Products (M) Sdn Bhd on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 61 510(k) clearances for Wembley Rubber Products (M) Sdn Bhd, from to . As of , FDA records show no recalls naming K903777.

Clearance record

Decision date
Received
(115 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Wembley Rubber Products (M) Sdn Bhd Peru Bandar Baru Salak Tinggi, Selangor, Malaysia, MY
Third party review
No

Clearances, product code EZL

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