GENADYNE A4 POWERED SUCTION PUMP— 510(k) K080745

Substantially Equivalent

Genadyne Biotechnologies, Inc.

FDA 510(k) clearance K080745 for GENADYNE A4 POWERED SUCTION PUMP, Substantially Equivalent on 2008-07-30. Applicant: Genadyne Biotechnologies, Inc..

Clearance details

Applicant: Genadyne Biotechnologies, Inc.
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 2008-03-17
Decision date: 2008-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Great Neck, NY, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.