4-WIRE (CARSON) STONE EXTRACTOR— 510(k) K863081

Substantially Equivalent

Cook Urological, Inc.

FDA 510(k) clearance K863081 for 4-WIRE (CARSON) STONE EXTRACTOR, Substantially Equivalent on 1986-10-24. Applicant: Cook Urological, Inc..

Clearance details

Applicant: Cook Urological, Inc.
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-12
Decision date: 1986-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.