510(k) K261338 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
RENASYS DYNAFLOW Kit (66807741)
| Applicant | Smith & Nephew Medical, Ltd., Hull, GB |
| Decision | Substantially Equivalent, Sep 11, 2026 |
| Received | Apr 23, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261338
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.