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FDA PRODUCT CODE · CLASS II

PDQ — Neurosurgical Nerve Locator

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

DEVICE CLASS
Class II
REGULATION
21 CFR 874.1820
MEDICAL SPECIALTY
Ear, Nose, Throat
REVIEW PANEL
NE
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K260992Neuralytix · 510k2026-06-25
K253580Tedan Surgical Innovations · 510k2026-04-26
K243636Neuralytix, LLC · 510k2025-06-26

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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