PDQ

Neurosurgical Nerve Locator

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-06-25.

NumberDecision dateApplicantDevice nameSummary
K2609922026-06-25NeuralytixiD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip…PDF
K2535802026-04-26Tedan Surgical InnovationsSterile Insulated Dilators, 5, 10, 16mm (MDT-0442S);…PDF
K2436362025-06-26Neuralytix, LLCNeuralytix iD3 System (NTX-9001)PDF

3 summaries are archived here for direct download.

Official FDA classification page: PDQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).