SILICATH ALL SILICONE FOLEY CATHETER— 510(k) K945806

Substantially Equivalent

Unomedical Sdn Bhd

FDA 510(k) clearance K945806 for SILICATH ALL SILICONE FOLEY CATHETER, Substantially Equivalent on 1995-03-21. Applicant: Unomedical Sdn Bhd.

Clearance details

Applicant: Unomedical Sdn Bhd
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 1994-11-28
Decision date: 1995-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sungai Petani, Kedah, 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.