FDA 510(k)

TIGR 矩陣外科網格

K 號：K163005 · 2017-07-27

決定日期2017-07-27

產品代碼OWT

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

TIGR Matrix Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Novus Scientific AB. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K163005. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TIGR Matrix Surgical Mesh?

TIGR Matrix Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-07-27. The listed applicant is Novus Scientific AB. The 510(k) number is K163005.

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

TIGR Matrix Surgical Mesh received FDA 510(k) clearance on 2017-07-27, under 510(k) number K163005.

Who is the listed applicant for TIGR Matrix Surgical Mesh?

The FDA 510(k) record lists Novus Scientific AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TIGR Matrix Surgical Mesh?

The FDA product code for TIGR Matrix Surgical Mesh is OWT.

其他以 Novus Scientific AB 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。

K191749TIGR 矩陣外科網膜，TIGR 外科網膜

相關器械（代碼：OWT）

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。

K243241Phasix ST 腹股溝癆補貼Davol, Inc., A Subsidiary of C.R. Bard, Inc.K233661Transorb™ 自粘性可吸收網格Sofradim Production K191749TIGR 矩陣外科網膜，TIGR 外科網膜Novus Scientific AB K191773GORE BIO-A 組織強化劑W. L. Gore & Associates, Inc.K190185Phasix ST 網狀結構搭配開放定位系統C.R. Bard, Inc.K173143Phasix ST 網狀物C.R. Bard, Inc.

官方來源

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