510(k) K260646 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS EDGE (66803126)
| Applicant | Smith & Nephew Medical, Ltd., Hull, GB |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Feb 27, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260646
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.