K243576
- 510(k) number
- K243576
- Device name
- RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port
- Applicant
- Smith & Nephew Medical, Ltd. GB
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2025-02-18
- Date received
- 2024-11-19
- 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: K243576.pdf
Official FDA record: K243576
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.