MONOJECT BONE MARROW BIOPSY TRAYS— 510(k) K945109

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K945109 for MONOJECT BONE MARROW BIOPSY TRAYS, Substantially Equivalent on 1994-11-14. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1994-10-18
Decision date: 1994-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.