iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007)— 510(k) K260992
Substantially EquivalentNeuralytix
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.
Summary
Neuralytix's clearance covers three iD3 probes: the Nav Decompression Probe (NTX-9005), the Ball Tip Stim Probe (NTX-9006), and the Nav Ball Tip Probe (NTX-9007). They're filed under PDQ, neurosurgical nerve locators.
Class II, 21 CFR 874.1820. The Neurology review panel handled it as a Traditional 510(k), though the record lists Ear, Nose, and Throat as the classification panel.
Neuralytix filed from Fruita, Colorado. Review took 91 calendar days (March 26 to June 25, 2026).
Clearance details
- Applicant
- Neuralytix
- Product code
- Product code PDQ
- Device class
- Class 2
- Regulation
- 21 CFR 874.1820
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fruita, CO, US
Recent devices under product code PDQ
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