FDA 510(k)

強力纖維縫線

K 號：K191268 · 2019-06-11

決定日期2019-06-11

產品代碼GAT

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

Force Fiber Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical Incorporated. It received FDA 510(k) clearance on 2019-06-11 under 510(k) number K191268. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Force Fiber Suture?

Force Fiber Suture is a medical device that received FDA 510(k) clearance on 2019-06-11. The listed applicant is Teleflex Medical Incorporated. The 510(k) number is K191268.

When did Force Fiber Suture receive FDA 510(k) clearance?

Force Fiber Suture received FDA 510(k) clearance on 2019-06-11, under 510(k) number K191268.

Who is the listed applicant for Force Fiber Suture?

The FDA 510(k) record lists Teleflex Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Force Fiber Suture?

The FDA product code for Force Fiber Suture is GAT.

其他以 Teleflex Medical Incorporated 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。

K181774Force Fiber 白色及白/藍色、白/黑色、藍色及白/綠色縫線；Force Fiber OrthoTape 縫線；Bondek 縫線及 Bondek Plus 縫線；Monodek 縫線；Polyglytone*6211 縫線 K172016強力纖維融合縫線

相關器械（代碼：GAT）

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。

K253910釘線 - 緝合針線及膠帶GM Dos Reis Industria e Comercio Ltda.K261021EasyWhip 家族Winter Innovations, Inc.K260775聚乙烯；聚乙烯融合；聚乙烯正骨膠帶™Teleflex Medical, LLC K254275超縫全綠延伸線Threadstone, LLC K254188半月板VersaflexGM Dos Reis Industria e Comercio Ltda.K253145預縫合腱Rti Surgical, Inc.

官方來源

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