MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED— 510(k) K883014

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K883014 for MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED, Substantially Equivalent on 1988-07-28. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code GAA
Advisory panel: General, Plastic Surgery
Date received: 1988-07-19
Decision date: 1988-07-28
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.