FDA 510(k)

巨環按鈕系統

K 號：K232941 · 2024-05-03

決定日期2024-05-03

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Megaloop Button System is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K232941. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Megaloop Button System?

Megaloop Button System is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Suzhou Endophix Co., Ltd.. The 510(k) number is K232941.

When did Megaloop Button System receive FDA 510(k) clearance?

Megaloop Button System received FDA 510(k) clearance on 2024-05-03, under 510(k) number K232941.

Who is the listed applicant for Megaloop Button System?

The FDA 510(k) record lists Suzhou Endophix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Megaloop Button System?

The FDA product code for Megaloop Button System is MBI.

其他以 Suzhou Endophix Co., Ltd. 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。

K232725Javelot Ti 緝合釘，Javelot Ti-D 緝合釘 K231002Javelot PK-S 緝合釘，Javelot PK-S 緝合釘（無結），Javelot PK-P 緝合釘，Javelot PK-P 緝合釘（無結），Javelot PK-L 緝合釘（無結）K230874Syntheface PEEK 交叉螺釘，Syntheface PEEK 螺釘套管

相關器械（代碼：MBI）

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。