510(k) K253581 ยท IKT Electrode, Needle, Diagnostic Electromyograph
Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Con
| Applicant | Technomed Europe, Kerkrade, NL |
| Decision | Substantially Equivalent, Mar 15, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253581
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.