K251646
- 510(k) number
- K251646
- Device name
- extriCARE® 1000 Negative Pressure Wound Therapy System
- Applicant
- Alleva Medical Devices CA · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2025-10-03
- Date received
- 2025-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K251646.pdf
Official FDA record: K251646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.