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FDA 510(k)

重輪外科網格

K 號：K170134 · 2017-08-09

申請人Iconlab, Inc.
決定日期2017-08-09
產品代碼FTL
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

Reperen Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Iconlab, Inc.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) number K170134. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reperen Surgical Mesh?

Reperen Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-08-09. The listed applicant is Iconlab, Inc.. The 510(k) number is K170134.

When did Reperen Surgical Mesh receive FDA 510(k) clearance?

Reperen Surgical Mesh received FDA 510(k) clearance on 2017-08-09, under 510(k) number K170134.

Who is the listed applicant for Reperen Surgical Mesh?

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

What is the FDA product code for Reperen Surgical Mesh?

The FDA product code for Reperen Surgical Mesh is FTL.

相關臨床試驗

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相關器械（代碼：FTL）

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。

K253956ProGrip™ 先進自緊握聚丙烯網格 (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ 平面網狀布Medtronic - Sofradim ProductionK251955Onflex™ 網狀物Davol Inc., Subsidiary of C. R. Bard, Inc.K251557巴德® 網膜；巴德® 預成型網膜Davol, Inc.K250869Parietene™ 大孔網膜 (PPM5050)Sofradim ProductionK250098巴德柔 mesh；巴德柔柔 mesh 預成型Davol, Inc.

官方來源

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