K250586
- 510(k) number
- K250586
- Device name
- Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory
- Applicant
- Deroyal Industries, Inc. TN · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2025-11-21
- Date received
- 2025-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250586.pdf
Official FDA record: K250586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.