PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X— 510(k) K013921

Substantially Equivalent

Porges S.A.

FDA 510(k) clearance K013921 for PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X, Substantially Equivalent on 2002-10-17. Applicant: Porges S.A..

Clearance details

Applicant: Porges S.A.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2001-11-27
Decision date: 2002-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Le Plessis Robinson Cedex, FR

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Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.