K230233
- 510(k) number
- K230233
- Device name
- Prospera Spectruum Negative Pressure Wound Therapy System
- Applicant
- Deroyal Industries, Inc. TN · US
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2024-04-18
- Date received
- 2023-01-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K230233.pdf
Official FDA record: K230233
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.