FDA 510(k)

GORE SEAMGUARD 生物可吸收釘線強化材

K 號：K181940 · 2018-08-17

決定日期2018-08-17

產品代碼OXC

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 SEAMGUARD Bioabsorbable Staple Line 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 2018-08-17 under 510(k) number K181940. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is W. L. Gore & Associates, Inc.. The 510(k) number is K181940.

When did GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement receive FDA 510(k) clearance?

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181940.

Who is the listed applicant for GORE SEAMGUARD Bioabsorbable Staple Line 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 SEAMGUARD Bioabsorbable Staple Line Reinforcement?

The FDA product code for GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement is OXC.

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：OXC）

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。

K252906ECHELON ENDOPATH 鍵線強化器 (ECH60R)Ethicon Endo-Surgery, LLC K231603標準釘線強化（SSLR23）Standard Bariatrics, Inc.K221343ECHELON ENDOPATH 鍵線強化器Ethicon Endo-Surgery, LLC K221487NEOVEIL 鋼釘線加固Gunze Limited K190937Echelon Endopath 粘合線強化設備Ethicon Endo-Surgery, LLC

官方來源

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