FDA 510(k)

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

K番号: K181620 · 2018-09-18

決定日2018-09-18

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

Endoscopic Linear Cutting Staplers and Loading Units 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 2018-09-18 under 510(k) number K181620. 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use is a medical device that received FDA 510(k) clearance on 2018-09-18. The listed applicant is Ezisurg (Suzhou) Medical Co., Ltd.. The 510(k) number is K181620.

When did Endoscopic Linear Cutting Staplers and Loading Units for Single Use receive FDA 510(k) clearance?

Endoscopic Linear Cutting Staplers and Loading Units for Single Use received FDA 510(k) clearance on 2018-09-18, under 510(k) number K181620.

Who is the listed applicant for Endoscopic Linear Cutting Staplers and Loading Units 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 Endoscopic Linear Cutting Staplers and Loading Units for Single Use?

The FDA product code for Endoscopic Linear Cutting Staplers and Loading Units 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

K182217一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

関連機器（コード：GDW）

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