510(k) K251197 ยท SDD Electromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field
Dexter L6 System
| Applicant | Distalmotion SA, Epalinges, CH |
| Decision | Substantially Equivalent, Sep 30, 2025 |
| Received | Apr 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251197
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.