SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8)— 510(k) K904793

Substantially Equivalent

Surgitek

FDA 510(k) clearance K904793 for SURGITEK GRADUATED URETEROSCOPE (MODEL GU-8), Substantially Equivalent on 1991-03-05. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 1990-10-23
Decision date: 1991-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.