510(k) K263010 ยท GWF Stimulator, Electrical, Evoked Response
ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
| Applicant | inomed Medizintechnik GmbH, Emmendingen, DE |
| Decision | Substantially Equivalent, Sep 24, 2026 |
| Received | Aug 28, 2026 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K263010
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.