Wovyn Depth Electrode— 510(k) K253970
Substantially EquivalentSensomedical Labs, Ltd.
FDA 510(k) clearance K253970 for Wovyn Depth Electrode, Substantially Equivalent on 2026-04-17. Applicant: Sensomedical Labs, Ltd.. Device class: 2.
Summary
Sensomedical Labs' Wovyn Depth Electrode is filed under product code GZL (Electrode, Depth).
Class II, 21 CFR 882.1330. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Sensomedical Labs filed from Nazareth, Israel. The decision came 127 calendar days after FDA received it (December 11, 2025 to April 17, 2026).
Clearance details
- Applicant
- Sensomedical Labs, Ltd.
- Product code
- Product code GZL
- Device class
- Class 2
- Regulation
- 21 CFR 882.1330
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nazareth, IL
Recent devices under product code GZL
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