K253580
- 510(k) number
- K253580
- Device name
- Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
- Applicant
- Tedan Surgical Innovations TX · US
- Product code
- PDQ — Neurosurgical Nerve Locator
- Decision date
- 2026-04-26
- Date received
- 2025-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253580.pdf
Official FDA record: K253580
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.