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FDA 510(k)

狼人電凝系統，電凝光環棒

K 號：K192027 · 2019-12-20

申請人ArthroCare Corporation
決定日期2019-12-20
產品代碼GEI
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

WEREWOLF COBLATION System, COBLATION HALO Wand is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K192027. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the WEREWOLF COBLATION System, COBLATION HALO Wand?

WEREWOLF COBLATION System, COBLATION HALO Wand is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is ArthroCare Corporation. The 510(k) number is K192027.

When did WEREWOLF COBLATION System, COBLATION HALO Wand receive FDA 510(k) clearance?

WEREWOLF COBLATION System, COBLATION HALO Wand received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192027.

Who is the listed applicant for WEREWOLF COBLATION System, COBLATION HALO Wand?

The FDA 510(k) record lists ArthroCare Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand?

The FDA product code for WEREWOLF COBLATION System, COBLATION HALO Wand is GEI.

相關臨床試驗

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其他以 ArthroCare Corporation 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。

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相關器械（代碼：GEI）

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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