HELICAL STONE/FLATWIRE STONE BASKETS— 510(k) K933260

Substantially Equivalent

Surgitek

FDA 510(k) clearance K933260 for HELICAL STONE/FLATWIRE STONE BASKETS, Substantially Equivalent on 1994-01-11. Applicant: Surgitek.

Clearance details

Applicant: Surgitek
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1993-07-06
Decision date: 1994-01-11
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.