SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT— 510(k) K913928

Substantially Equivalent

Surgitek Medical Engineering Corp.

FDA 510(k) clearance K913928 for SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT, Substantially Equivalent on 1991-11-19. Applicant: Surgitek Medical Engineering Corp..

Clearance details

Applicant: Surgitek Medical Engineering Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 1991-09-03
Decision date: 1991-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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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.