FDA 510(k)

Wovyn Depth Electrode

K-Number: K253970 · 2026-04-17

Decision Date2026-04-17

Product CodeGZL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Wovyn Depth Electrode is a medical device manufactured by Sensomedical Labs, Ltd.. It received FDA 510(k) clearance on 2026-04-17 under approval number K253970. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wovyn Depth Electrode?

Wovyn Depth Electrode is a medical device that received FDA 510(k) clearance on 2026-04-17. It is manufactured by Sensomedical Labs, Ltd.. The 510(k) number is K253970.

When was Wovyn Depth Electrode approved by the FDA?

Wovyn Depth Electrode received FDA 510(k) clearance on 2026-04-17, under approval number K253970.

What company makes Wovyn Depth Electrode?

Wovyn Depth Electrode is manufactured by Sensomedical Labs, Ltd..

What is the FDA product code for Wovyn Depth Electrode?

The FDA product code for Wovyn Depth Electrode is GZL.

Related Clinical Trials

NCT05427929 Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance ACTIVE_NOT_RECRUITING

Other Devices by Sensomedical Labs, Ltd.

K213170SENSOSEEG Depth Electrodes

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.