Wovyn Depth Electrode— 510(k) K253970

Substantially Equivalent

Sensomedical Labs, Ltd.

FDA 510(k) clearance K253970 for Wovyn Depth Electrode, Substantially Equivalent on 2026-04-17. Applicant: Sensomedical Labs, Ltd..

Clearance details

Applicant: Sensomedical Labs, Ltd.
Product code: Code GZL
Advisory panel: Neurology
Date received: 2025-12-11
Decision date: 2026-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nazareth, IL

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