FDA 510(k)

EasyClip Xpress

K番号: K162321 · 2017-02-10

決定日2017-02-10

製品コードJDR

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

EasyClip Xpress is the device name listed in this FDA 510(k) record. The listed applicant is Restore Surgical, LLC Dba Instratek. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K162321. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the EasyClip Xpress?

EasyClip Xpress is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Restore Surgical, LLC Dba Instratek. The 510(k) number is K162321.

When did EasyClip Xpress receive FDA 510(k) clearance?

EasyClip Xpress received FDA 510(k) clearance on 2017-02-10, under 510(k) number K162321.

Who is the listed applicant for EasyClip Xpress?

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

What is the FDA product code for EasyClip Xpress?

The FDA product code for EasyClip Xpress is JDR.

申請者としてRestore Surgical, LLC Dba Instratekを記載するその他の記録

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