FDA 510(k)

TroClose1200, TroClose1200 管針

K 號：K171494 · 2017-06-15

決定日期2017-06-15

產品代碼GAM

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

TroClose1200, TroClose1200 Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Gordian Surgical, Ltd.. It received FDA 510(k) clearance on 2017-06-15 under 510(k) number K171494. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TroClose1200, TroClose1200 Cannula?

TroClose1200, TroClose1200 Cannula is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Gordian Surgical, Ltd.. The 510(k) number is K171494.

When did TroClose1200, TroClose1200 Cannula receive FDA 510(k) clearance?

TroClose1200, TroClose1200 Cannula received FDA 510(k) clearance on 2017-06-15, under 510(k) number K171494.

Who is the listed applicant for TroClose1200, TroClose1200 Cannula?

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

What is the FDA product code for TroClose1200, TroClose1200 Cannula?

The FDA product code for TroClose1200, TroClose1200 Cannula is GAM.

其他以 Gordian Surgical, 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。

K253620TroClose 1200 K160564TroClose1200

相關器械（代碼：GAM）

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。

K253394包覆維克萊™（多甘膠910）加抗菌縫線ETHICON, Inc.K253530Trexon™ 单絲合成可吸收縫線Medtronic K253852MONOCRYL™ Plus 抗菌多甘露聚糖 - 25（單絲），无菌合成可吸收外科縫線ETHICON, Inc.K252743STRATAFIX™螺旋PDS™ Plus無結紮組織控制裝置；STRATAFIX™螺旋MONOCRYL™無結紮組織控制裝置ETHICON, Inc.K253620TroClose 1200Gordian Surgical, Ltd.K252820PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（卡利普索）；PGLA90 聚(甘醇酸-共-L-乳酸)外科縫線（奧德賽斯）Internacional Farmacéutica S.A DE C.V

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。