FDA 510(k)

disposable ラインナーステイプラー、disposable ラインカッター

K番号: K172538 · 2017-11-30

申請者Changzhou Kangdi Medical Stapler Co., Ltd.

決定日2017-11-30

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 Linear Stapler, Disposable Linear Cutter is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. It received FDA 510(k) clearance on 2017-11-30 under 510(k) number K172538. 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 Linear Stapler, Disposable Linear Cutter?

Disposable Linear Stapler, Disposable Linear Cutter is a medical device that received FDA 510(k) clearance on 2017-11-30. The listed applicant is Changzhou Kangdi Medical Stapler Co., Ltd.. The 510(k) number is K172538.

When did Disposable Linear Stapler, Disposable Linear Cutter receive FDA 510(k) clearance?

Disposable Linear Stapler, Disposable Linear Cutter received FDA 510(k) clearance on 2017-11-30, under 510(k) number K172538.

Who is the listed applicant for Disposable Linear Stapler, Disposable Linear Cutter?

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

What is the FDA product code for Disposable Linear Stapler, Disposable Linear Cutter?

The FDA product code for Disposable Linear Stapler, Disposable Linear Cutter is GDW.

申請者としてChangzhou Kangdi Medical Stapler Co., Ltd.を記載するその他の記録

K172561disposable circular stapler

関連機器（コード：GDW）

公式ソース

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