K253970
- 510(k) number
- K253970
- Device name
- Wovyn Depth Electrode
- Applicant
- Sensomedical Labs, Ltd. IL
- Product code
- GZL — Electrode, Depth
- Decision date
- 2026-04-17
- Date received
- 2025-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K253970.pdf
Official FDA record: K253970
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.