K232632
- 510(k) number
- K232632
- Device name
- Racz Neurostat RF Generator
- Applicant
- Epimed International NY · US
- Product code
- GXD — Generator, Lesion, Radiofrequency
- Decision date
- 2024-05-24
- Date received
- 2023-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K232632.pdf
Official FDA record: K232632
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.