ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM— 510(k) K120499
Substantially EquivalentKci USA, Inc. (Kinetic Concepts, Inc.)
FDA 510(k) clearance K120499 for ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, Substantially Equivalent on 2012-10-05. Applicant: 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
- Decision date
- 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, through . 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.