510(k) K243187 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100)
| Applicant | Cork Medical, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 27, 2025 |
| Received | Sep 30, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243187
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.