510(k) K253153 ยท QAI Powered Microneedle Device
SER Pen Carain MicroSystem (MP1209SP)
| Applicant | Su-Ko Technologies, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Oct 29, 2025 |
| Received | Sep 26, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253153
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.