FDA 510(k)

ECHELON ENDOPATH 鍵線強化器

K 號：K221343 · 2022-09-16

決定日期2022-09-16

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

ECHELON ENDOPATH Staple Line Reinforcement is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221343. 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 ECHELON ENDOPATH Staple Line Reinforcement?

ECHELON ENDOPATH Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K221343.

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

ECHELON ENDOPATH Staple Line Reinforcement received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221343.

Who is the listed applicant for ECHELON ENDOPATH Staple Line Reinforcement?

FDA 510(k) 記錄中將 Ethicon Endo-Surgery, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for ECHELON ENDOPATH Staple Line Reinforcement?

The FDA product code for ECHELON ENDOPATH Staple Line Reinforcement is OXC.

其他以 Ethicon Endo-Surgery, LLC 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。

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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.K221487NEOVEIL 鋼釘線加固Gunze Limited K190937Echelon Endopath 粘合線強化設備Ethicon Endo-Surgery, LLC K181940GORE SEAMGUARD 生物可吸收釘線強化材W. L. Gore & Associates, Inc.

官方來源

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