Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S)
Device Facts
| Record ID | K253580 |
|---|---|
| Device Name | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) |
| Applicant | Tedan Surgical Innovations |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Apr 26, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
