FDA 510(k)

導向式DAS外科工具組

K 號：K243425 · 2025-07-22

決定日期2025-07-22

產品代碼KCT

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

Guided DAS Surgical Kit is the device name listed in this FDA 510(k) record. The listed applicant is Talladium España, SL. It received FDA 510(k) clearance on 2025-07-22 under 510(k) number K243425. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Guided DAS Surgical Kit?

Guided DAS Surgical Kit is a medical device that received FDA 510(k) clearance on 2025-07-22. The listed applicant is Talladium España, SL. The 510(k) number is K243425.

When did Guided DAS Surgical Kit receive FDA 510(k) clearance?

Guided DAS Surgical Kit received FDA 510(k) clearance on 2025-07-22, under 510(k) number K243425.

Who is the listed applicant for Guided DAS Surgical Kit?

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

What is the FDA product code for Guided DAS Surgical Kit?

The FDA product code for Guided DAS Surgical Kit is KCT.

其他以 Talladium España, SL 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：KCT）

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。

K253988LiteSet 盤子Nobel Biocare AB K261935外科及義肢托盤Dentsply Sirona, Inc.K253187SteriBest® 過濾消毒托盤系統Mastel Surgical K252854SteriTite容器系統搭配MediTray產品Case Medical, Inc.K260726斯特羅曼® ProClean™ 裝籠 (041.800 ; 041.801)Institut Straumann AG K253791PUREVUE™ 快速連接針筒系統托盤；PUREVUE™ 快速連接針筒系統蓋DePuy Mitek, Inc.

官方來源

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