BONE AND MARROW COLLECTION SYSTEM KIT— 510(k) K971782

Substantially Equivalent

Biomedical Ent., Inc.

FDA 510(k) clearance K971782 for BONE AND MARROW COLLECTION SYSTEM KIT, Substantially Equivalent on 1997-07-29. Applicant: Biomedical Ent., Inc..

Clearance details

Applicant: Biomedical Ent., Inc.
Product code: Code GEY
Advisory panel: General, Plastic Surgery
Date received: 1997-05-14
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

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.