510(k) K261987 ยท EKX Handpiece, Direct Drive, Ac-Powered
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| Applicant | Osstell AB, Goteborg, SE |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Jun 12, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261987
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.