FDA 510(k)

沃威恩深度電極

K 號：K253970 · 2026-04-17

決定日期2026-04-17

產品代碼GZL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

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

常見問題

What is the Wovyn Depth Electrode?

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

When did Wovyn Depth Electrode receive FDA 510(k) clearance?

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

Who is the listed applicant for Wovyn Depth Electrode?

The FDA 510(k) record lists Sensomedical Labs, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wovyn Depth Electrode?

The FDA product code for Wovyn Depth Electrode is GZL.

其他以 Sensomedical Labs, Ltd. 為申請人之記錄

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K213170感應式深度電極

相關器械（代碼：GZL）

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官方來源

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