K254019
- 510(k) number
- K254019
- Device name
- Wound Geni NPWT System
- Applicant
- Bechtel Medical, Inc. PA · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2026-05-04
- Date received
- 2025-12-15
- 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: K254019.pdf
Official FDA record: K254019
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.