V.A.C. PLUS— 510(k) K992448

Substantially Equivalent

Kinetic Concepts, Inc.

FDA 510(k) clearance K992448 for V.A.C. PLUS, Substantially Equivalent on 2000-01-18. Applicant: Kinetic Concepts, Inc..

Clearance details

Applicant: Kinetic Concepts, Inc.
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 1999-07-22
Decision date: 2000-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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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.