K991178

Substantially Equivalent

FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253

Applicant: Richard Wolf Medical Instruments Corp.
Product code: FGB
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-07
Decision date: 1999-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, US

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.