FDA 510(k)

一次性可動內視鏡線性切斷釘釘器及補充包

K 號：K182476 · 2019-12-18

決定日期2019-12-18

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 Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Fengh Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K182476. 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 Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Fengh Medical Co., Ltd.. The 510(k) number is K182476.

When did Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads receive FDA 510(k) clearance?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads received FDA 510(k) clearance on 2019-12-18, under 510(k) number K182476.

Who is the listed applicant for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

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

What is the FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

The FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is GDW.

其他以 Fengh Medical 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。

K242679一次性使用可動式內視鏡線性切刀釘合器及重裝件（30mm系列）；一次性使用可動式內視鏡線性切刀釘合器及重裝件（45mm系列）；一次性使用可動式內視鏡線性切刀釘合器及重裝件（60mm系列）K202467一次性可動內視鏡線性切斷釘釘器及補充包 K180208一次性內視鏡穿刺針

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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