510(k) K253580 ยท PDQ Neurosurgical Nerve Locator
Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
| Applicant | Tedan Surgical Innovations, Sugar Land TX, US |
| Decision | Substantially Equivalent, Apr 26, 2026 |
| Received | Nov 17, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253580
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.