Clearance Summary
iD3 Nav Decompression Probe (NTX-9005); iD3 Ball Tip Stim Probe (NTX-9006); iD3 Nav Ball Tip Probe (NTX-9007) received FDA 510(k) clearance under submission number K260992, sponsored by Neuralytix. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2026-06-25.
- Submission: K260992
- Applicant / Sponsor: Neuralytix
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.1820
- Decision date: 2026-06-25
Classification & Regulation
This clearance is catalogued under FDA product code PDQ and 21 CFR 874.1820, within the Ear, Nose, Throat review panel as a Class II device.