iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)
Device Facts
| Record ID | K260992 |
|---|---|
| Device Name | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) |
| Applicant | Neuralytix |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Jun 25, 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.