510(k) K100657— V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL U

Substantially Equivalent

Kci USA, Inc. (Kinetic Concepts, Inc.)

Clearance details

Applicant: Kci USA, Inc. (Kinetic Concepts, Inc.)
Product code: Code OMP
Advisory panel: General, Plastic Surgery
Date received: 2010-03-08
Decision date: 2010-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

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.