FDA 510(k)

NUVENTUS NV.C™ 外科儀器盒及托盤

K 號：K243317 · 2025-02-11

決定日期2025-02-11

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

NUVENTUS NV.C™ Surgical Cassette and Tray is the device name listed in this FDA 510(k) record. The listed applicant is Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2025-02-11 under 510(k) number K243317. 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 NUVENTUS NV.C™ Surgical Cassette and Tray?

NUVENTUS NV.C™ Surgical Cassette and Tray is a medical device that received FDA 510(k) clearance on 2025-02-11. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K243317.

When did NUVENTUS NV.C™ Surgical Cassette and Tray receive FDA 510(k) clearance?

NUVENTUS NV.C™ Surgical Cassette and Tray received FDA 510(k) clearance on 2025-02-11, under 510(k) number K243317.

Who is the listed applicant for NUVENTUS NV.C™ Surgical Cassette and Tray?

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

What is the FDA product code for NUVENTUS NV.C™ Surgical Cassette and Tray?

The FDA product code for NUVENTUS NV.C™ Surgical Cassette and Tray is KCT.

其他以 Infinitum Eta, 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。

K251220NUVENTUS NV.C™ 假肢零件 K233081NUVENTUS NV.C™ 齿植系統

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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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。