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FDA 510(k)

EndoFix™組織固定系統

K 號：K251229 · 2025-08-20

申請人Softac Medical Technologies
決定日期2025-08-20
產品代碼FGE
諮詢委員會GU
決定相當於

器材摘要

EndoFix™Tissue Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Softac Medical Technologies. It received FDA 510(k) clearance on 2025-08-20 under 510(k) number K251229. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EndoFix™Tissue Fixation System?

EndoFix™Tissue Fixation System is a medical device that received FDA 510(k) clearance on 2025-08-20. The listed applicant is Softac Medical Technologies. The 510(k) number is K251229.

When did EndoFix™Tissue Fixation System receive FDA 510(k) clearance?

EndoFix™Tissue Fixation System received FDA 510(k) clearance on 2025-08-20, under 510(k) number K251229.

Who is the listed applicant for EndoFix™Tissue Fixation System?

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

What is the FDA product code for EndoFix™Tissue Fixation System?

The FDA product code for EndoFix™Tissue Fixation System is FGE.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：FGE）

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。

K254179引流針管Canyon Medical, Inc.K262913Protégé™ EverFlex™ 自擴張週邊支架系統Medtronic, Inc.K260835阿基米德可生物降解支架（中號）Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.)K253393單次使用氣球擴張導管（AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019 AG-5251-085519 AG-5251-088019 AG-5251-083021 AG-5251-085521 AG-5251-088021 AG-5251-083024 AG-5251-085524 AG-5251-088024 AG-5251-103018 AG-5251-105518 AG-5251-108018 AG-5251-103019 AG-5251-105519 AG-5251-108019 AG-5251-103021 AG-5251-105521 AG-5251-108021 AG-5251-103024 AG-5251-105524 AG-5251-108024 AG-5251-123018 AG-5251-125518 AG-5251-128018 AG-5251-123019 AG-5251-125519 AG-5251-128019）Hangzhou AGS MedTech Co., Ltd.K253832擴張氣球心导管Mirco-Tech (Nanjing) Co., Ltd.K251658Endoflux™ 胆胰支架組Medi-Globe GmbH

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