510(k) K253677 ยท KRD Device, Vascular, For Promoting Embolization
Tembo Embolic System
| Applicant | Instylla, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 15, 2025 |
| Received | Nov 21, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K253677
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.