extriCARE® 1000 Negative Pressure Wound Therapy System— 510(k) K251646
Substantially EquivalentAlleva Medical Devices
FDA 510(k) clearance K251646 for extriCARE® 1000 Negative Pressure Wound Therapy System, Substantially Equivalent on 2025-10-03. Applicant: Alleva Medical Devices.
Clearance details
- Applicant
- Alleva Medical Devices
- Product code
- Code OMP
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, 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.