FDA 510(k)

Cobbra RF 絲維分離器

K 號：K160041 · 2016-03-07

決定日期2016-03-07

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

Cobbra RF Tissue Dissector is the device name listed in this FDA 510(k) record. The listed applicant is Elliquence, LLC. It received FDA 510(k) clearance on 2016-03-07 under 510(k) number K160041. 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 Cobbra RF Tissue Dissector?

Cobbra RF Tissue Dissector is a medical device that received FDA 510(k) clearance on 2016-03-07. The listed applicant is Elliquence, LLC. The 510(k) number is K160041.

When did Cobbra RF Tissue Dissector receive FDA 510(k) clearance?

Cobbra RF Tissue Dissector received FDA 510(k) clearance on 2016-03-07, under 510(k) number K160041.

Who is the listed applicant for Cobbra RF Tissue Dissector?

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

What is the FDA product code for Cobbra RF Tissue Dissector?

The FDA product code for Cobbra RF Tissue Dissector is GEI.

其他以 Elliquence, LLC 為申請人之記錄

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