FDA 510(k)

disposable endoscopic cutter stapler and cartridge

K番号: K211197 · 2023-01-19

申請者Changzhou Waston Medical Appliance Co., Ltd.

決定日2023-01-19

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

Disposable Endoscopic Cutter Stapler and Cartridge is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Waston Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2023-01-19 under 510(k) number K211197. 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 Disposable Endoscopic Cutter Stapler and Cartridge?

Disposable Endoscopic Cutter Stapler and Cartridge is a medical device that received FDA 510(k) clearance on 2023-01-19. The listed applicant is Changzhou Waston Medical Appliance Co., Ltd.. The 510(k) number is K211197.

When did Disposable Endoscopic Cutter Stapler and Cartridge receive FDA 510(k) clearance?

Disposable Endoscopic Cutter Stapler and Cartridge received FDA 510(k) clearance on 2023-01-19, under 510(k) number K211197.

Who is the listed applicant for Disposable Endoscopic Cutter Stapler and Cartridge?

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

What is the FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge?

The FDA product code for Disposable Endoscopic Cutter Stapler and Cartridge is GDW.

関連機器（コード：GDW）

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GDW）

公式ソース