K243636
- 510(k) number
- K243636
- Device name
- Neuralytix iD3 System (NTX-9001)
- Applicant
- Neuralytix, LLC CO · US
- Product code
- PDQ — Neurosurgical Nerve Locator
- Decision date
- 2025-06-26
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243636.pdf
Official FDA record: K243636
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.