PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,— 510(k) K013174

Substantially Equivalent

Porges S.A.

FDA 510(k) clearance K013174 for PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL,, Substantially Equivalent on 2002-01-04. Applicant: Porges S.A..

Clearance details

Applicant: Porges S.A.
Product code: Code EZL
Advisory panel: Gastroenterology, Urology
Date received: 2001-09-24
Decision date: 2002-01-04
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sarlat, FR

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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.