Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System— 510(k) K180855
Substantially EquivalentKci USA, Inc.
FDA 510(k) clearance K180855 for Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System, Substantially Equivalent on 2018-06-01. Applicant: Kci USA, Inc..
Clearance details
- Applicant
- Kci USA, 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.