FDA 510(k)

AceConnex 預縫合筋膜

K 號：K213046 · 2023-06-27

決定日期2023-06-27

產品代碼GAT

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

AceConnex Pre-Sutured Fascia is the device name listed in this FDA 510(k) record. The listed applicant is Allosource. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K213046. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AceConnex Pre-Sutured Fascia?

AceConnex Pre-Sutured Fascia is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Allosource. The 510(k) number is K213046.

When did AceConnex Pre-Sutured Fascia receive FDA 510(k) clearance?

AceConnex Pre-Sutured Fascia received FDA 510(k) clearance on 2023-06-27, under 510(k) number K213046.

Who is the listed applicant for AceConnex Pre-Sutured Fascia?

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

What is the FDA product code for AceConnex Pre-Sutured Fascia?

The FDA product code for AceConnex Pre-Sutured Fascia is GAT.

其他以 Allosource 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。

K170957ReConnex 預縫合腱

相關器械（代碼：GAT）

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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官方來源

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