510(k) K243636
K243636 is an FDA 510(k) premarket notification submitted by Neuralytix, LLC for the device "Neuralytix iD3 System (NTX-9001)". The FDA issued a decision of Substantially Equivalent on June 26, 2025. The device falls under product code PDQ (Neurosurgical Nerve Locator), a Class II device regulated under 21 CFR 874.1820. Neuralytix, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 26, 2025
- Date Received
- November 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Nerve Locator
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- NE
- Submission Type
To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.