BIOACCESS MARROW HARVEST SYSTEM— 510(k) K971114

Substantially Equivalent

Bioaccess, Inc.

FDA 510(k) clearance K971114 for BIOACCESS MARROW HARVEST SYSTEM, Substantially Equivalent on 1997-06-03. Applicant: Bioaccess, Inc..

Clearance details

Applicant: Bioaccess, Inc.
Product code: Code GDM
Advisory panel: General, Plastic Surgery
Date received: 1997-03-26
Decision date: 1997-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Silver Spring, MD, US

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Adverse events under product code GDM

product code GDM

Death: 2
Total: 2

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.