iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)— 510(k) K260992

Name: FDA 510(k) clearance K260992
Creator: U.S. Food and Drug Administration
Published: 2026-06-25

Substantially Equivalent

Neuralytix

FDA 510(k) clearance K260992 for iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007), Substantially Equivalent on 2026-06-25. Applicant: Neuralytix. Device class: 2.

Clearance details

Applicant: Neuralytix
Product code: Code PDQ
Device class: Class 2
Regulation: 21 CFR 874.1820
Advisory panel: Ear, Nose, Throat
Date received: 2026-03-26
Decision date: 2026-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fruita, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.