FDA 510(k)

一回使用用の線形カッター留置器およびローディングユニット、一回使用用の円形留置器

K番号: K182217 · 2019-04-16

決定日2019-04-16

製品コードGDW

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-04-16 under 510(k) number K182217. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is a medical device that received FDA 510(k) clearance on 2019-04-16. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K182217.

When did Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use receive FDA 510(k) clearance?

Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use received FDA 510(k) clearance on 2019-04-16, under 510(k) number K182217.

Who is the listed applicant for Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

The FDA 510(k) record lists Ezisurg (Suzhou) Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use?

The FDA product code for Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use is GDW.

申請者としてEzisurg (Suzhou) Medical Co., Ltd.を記載するその他の記録

K181620内視鏡用一次使用線形切結器およびローディングユニット

関連機器（コード：GDW）

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