510(k) K253199 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
CURASYS 2 (EMDN0003)
| Applicant | CG Bio Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Jun 23, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253199
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.