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FDA 510(k)

Advanced 冷冻皮肤疣去除器（Advanced 皮肤疣去除器）

K 號：K252198 · 2026-04-02

申請人Medical Brands Laboratories B.V.
決定日期2026-04-02
產品代碼GEH
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is the device name listed in this FDA 510(k) record. The listed applicant is Medical Brands Laboratories B.V.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K252198. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Medical Brands Laboratories B.V.. The 510(k) number is K252198.

When did Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) receive FDA 510(k) clearance?

Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) received FDA 510(k) clearance on 2026-04-02, under 510(k) number K252198.

Who is the listed applicant for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

The FDA 510(k) record lists Medical Brands Laboratories B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)?

The FDA product code for Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) is GEH.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Medical Brands Laboratories B.V. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K242288Advanced 冷冻疣去除器

相關器械（代碼：GEH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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