FDA 510(k)

Aesculap Aicon® 系列容器系統

K 號：K242762 · 2025-05-13

決定日期2025-05-13

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

Aesculap Aicon® Series Container System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2025-05-13 under 510(k) number K242762. 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 Aesculap Aicon® Series Container System?

Aesculap Aicon® Series Container System is a medical device that received FDA 510(k) clearance on 2025-05-13. The listed applicant is Aesculap, Inc.. The 510(k) number is K242762.

When did Aesculap Aicon® Series Container System receive FDA 510(k) clearance?

Aesculap Aicon® Series Container System received FDA 510(k) clearance on 2025-05-13, under 510(k) number K242762.

Who is the listed applicant for Aesculap Aicon® Series Container System?

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

What is the FDA product code for Aesculap Aicon® Series Container System?

The FDA product code for Aesculap Aicon® Series Container System is KCT.

其他以 Aesculap, Inc. 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。

K242003XABO 心室針，XABO 腹膜針，XABO 針套組 K223596SQ.line 賽里遜 K214041Aesculap AICON 容器 K211572Aesculap Slim Clip Applier K203739ELAN 4 電機系統 K202391DIR 800

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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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