510(k) K260984 ยท HIH Hysteroscope (And Accessories)
HERizon RD5 Resecting Device (5FR1PK);HERizon RD5 Resecting Device - 5 pack (5FR5PK)
| Applicant | Axora Medical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 18, 2026 |
| Received | Mar 25, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260984
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.