PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL— 510(k) K013172

Substantially Equivalent

Porges S.A.

FDA 510(k) clearance K013172 for PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL, Substantially Equivalent on 2001-12-20. 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: 2001-12-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Le Plessis Robinson Cedex, 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.