GENADYNE A4-XLR8 WOUND VACUUM SYSTEM— 510(k) K090638

Substantially Equivalent

Genadyne Biotechnologies, Inc.

FDA 510(k) clearance K090638 for GENADYNE A4-XLR8 WOUND VACUUM SYSTEM, Substantially Equivalent on 2009-04-29. Applicant: Genadyne Biotechnologies, Inc..

Clearance details

Applicant: Genadyne Biotechnologies, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2009-03-10
Decision date: 2009-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.