Rusch SoftSimplastic Foley Catheters— 510(k) K252537

Substantially Equivalent

Teleflex Medical Sdn. Bhd.

FDA 510(k) clearance K252537 for Rusch SoftSimplastic Foley Catheters, Substantially Equivalent on 2026-01-20. Applicant: Teleflex Medical Sdn. Bhd..

Clearance details

Applicant: Teleflex Medical Sdn. Bhd.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2025-08-12
Decision date: 2026-01-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kamunting, 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.