510(k) K252591 ยท QAI Powered Microneedle Device
Automatic Micro Needle System (CODE-X)
| Applicant | Woorhi Mechatronics Co., Ltd., Gunpo-Si, KR |
| Decision | Substantially Equivalent, May 13, 2026 |
| Received | Aug 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252591
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.