WILSON-COOK STONE EXTRACTOR— 510(k) K851965

Substantially Equivalent

Wilson-Cook Medical, Inc.

FDA 510(k) clearance K851965 for WILSON-COOK STONE EXTRACTOR, Substantially Equivalent on 1985-07-29. Applicant: Wilson-Cook Medical, Inc..

Clearance details

Applicant: Wilson-Cook Medical, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-03
Decision date: 1985-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, 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.