K250708
- 510(k) number
- K250708
- Device name
- NPseal
- Applicant
- Guard Medical, Inc. FL · US
- Product code
- OKO — Negative Pressure Wound Therapy Non-Powered Suction
- Decision date
- 2025-04-08
- Date received
- 2025-03-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250708.pdf
Official FDA record: K250708
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.