WRP FOLEYCATH— 510(k) K903777

Substantially Equivalent

Wembley Rubber Products (M) Sdn Bhd

FDA 510(k) clearance K903777 for WRP FOLEYCATH, Substantially Equivalent on 1990-12-13. Applicant: Wembley Rubber Products (M) Sdn Bhd.

Clearance details

Applicant: Wembley Rubber Products (M) Sdn Bhd
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1990-08-20
Decision date: 1990-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Selangor, Malaysia, MY

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZL

product code EZL

Death: 6
Injury: 796
Malfunction: 4,989
Other: 1
Total: 5,792

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.