FDA 510(k)

生物設計釘線加固設備

K 號：K170945 · 2017-04-28

決定日期2017-04-28

產品代碼OXE

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

Biodesign Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is Cook Biotech Incorporated. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K170945. The device is classified under product code OXE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biodesign Staple Line Reinforcement?

Biodesign Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is Cook Biotech Incorporated. The 510(k) number is K170945.

When did Biodesign Staple Line Reinforcement receive FDA 510(k) clearance?

Biodesign Staple Line Reinforcement received FDA 510(k) clearance on 2017-04-28, under 510(k) number K170945.

Who is the listed applicant for Biodesign Staple Line Reinforcement?

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

What is the FDA product code for Biodesign Staple Line Reinforcement?

The FDA product code for Biodesign Staple Line Reinforcement is OXE.

其他以 Cook Biotech 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。

K232646生物設計耳科蝴蝶移植片（ENT-OTO-BFLY-0.4-0.6）；生物設計耳科蝴蝶移植片（ENT-OTO-BFLY-0.6-0.9）K201000生物設計釘線加固設備 K191696生物設計肛門瘍塞，生物設計瘍塞，生物設計整形外科網格，生物設計組織移植 K171817生物設計橫隔膜裂移植片 K162934生物設計旁肛門裂孔修復移植物 K170016生物設計造口塞

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相關器械（代碼：OXE）

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。

K153364Kerecis SecureMeshKerecis Limited

官方來源

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