FDA 510(k)

GORE BIO-A 組織強化劑

K 號：K191773 · 2019-07-31

決定日期2019-07-31

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

GORE BIO-A Tissue Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191773. 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 GORE BIO-A Tissue Reinforcement?

GORE BIO-A Tissue Reinforcement is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K191773.

When did GORE BIO-A Tissue Reinforcement receive FDA 510(k) clearance?

GORE BIO-A Tissue Reinforcement received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191773.

Who is the listed applicant for GORE BIO-A Tissue Reinforcement?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GORE BIO-A Tissue Reinforcement?

The FDA product code for GORE BIO-A Tissue Reinforcement is OWT.

其他以 W. L. Gore & Associates, Inc. 為申請人之記錄

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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 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.K163005TIGR 矩陣外科網格Novus Scientific AB

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