STONE BASKET— 510(k) K914505

Substantially Equivalent

Surgitek Medical Engineering Corp.

FDA 510(k) clearance K914505 for STONE BASKET, Substantially Equivalent on 1991-12-09. Applicant: Surgitek Medical Engineering Corp..

Clearance details

Applicant: Surgitek Medical Engineering Corp.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1991-10-09
Decision date: 1991-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Racine, WI, US

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Adverse events under product code FFL

product code FFL

Death: 2
Injury: 270
Malfunction: 2,711
Other: 2
Total: 2,985

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.