K260646
- 510(k) number
- K260646
- Device name
- RENASYS EDGE (66803126)
- Applicant
- Smith & Nephew Medical, Ltd. GB
- Product code
- OMP — Negative Pressure Wound Therapy Powered Suction Pump
- Decision date
- 2026-05-27
- Date received
- 2026-02-27
- 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: K260646.pdf
Official FDA record: K260646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.