K260992

iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)

510(k) number
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 CO · US
Product code
PDQ — Neurosurgical Nerve Locator
Decision date
2026-06-25
Date received
2026-03-26
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K260992.pdf

Official FDA record: K260992
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.