STONE AND RETRIEVAL BASKET— 510(k) K792344

Substantially Equivalent

Mill-Rose Laboratory

FDA 510(k) clearance K792344 for STONE AND RETRIEVAL BASKET, Substantially Equivalent on 1979-12-20. Applicant: Mill-Rose Laboratory.

Clearance details

Applicant: Mill-Rose Laboratory
Product code: Code FFL
Advisory panel: Gastroenterology, Urology
Date received: 1979-11-19
Decision date: 1979-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.