FDA 510(k)

PlasmaBlade TnA 鼻咽扁桃腺及腺體切除設備

K 號：K152703 · 2016-07-08

決定日期2016-07-08

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

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K152703. 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 PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K152703.

When did PlasmaBlade TnA Tonsil and Adenoid Dissection Device receive FDA 510(k) clearance?

PlasmaBlade TnA Tonsil and Adenoid Dissection Device received FDA 510(k) clearance on 2016-07-08, under 510(k) number K152703.

Who is the listed applicant for PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

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

What is the FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device?

The FDA product code for PlasmaBlade TnA Tonsil and Adenoid Dissection Device is GEI.

其他以 Medtronic Advanced Energy 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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