FDA 510(k)

一次性直線釘針器，一次性直線切刀

K 號：K172538 · 2017-11-30

申請人Changzhou Kangdi Medical Stapler Co., Ltd.

決定日期2017-11-30

產品代碼GDW

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Changzhou Kangdi Medical Stapler Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K172561一次性環形釘釘器

相關器械（代碼：GDW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

官方來源

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