PDQ
- Product code
- PDQ
- Device name
- Neurosurgical Nerve Locator
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.1820
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
FDA classification definition
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260992 | 2026-06-25 | Neuralytix | iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip… | |
| K253580 | 2026-04-26 | Tedan Surgical Innovations | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S);… | |
| K243636 | 2025-06-26 | Neuralytix, LLC | Neuralytix iD3 System (NTX-9001) |
Official FDA classification page: PDQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).