V.A.C.ULTA Negative Pressure Wound Therapy System— 510(k) K203316
Substantially EquivalentKci, A Part of 3M Health Care Business Group
FDA 510(k) clearance K203316 for V.A.C.ULTA Negative Pressure Wound Therapy System, Substantially Equivalent on 2021-10-27. Applicant: Kci, A Part of 3M Health Care Business Group.
Clearance details
- Applicant
- Kci, A Part of 3M Health Care Business Group
- 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.