FDA 510(k)

SteriTite容器系統搭配MediTray產品

K 號：K252854 · 2026-06-03

決定日期2026-06-03

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

SteriTite Container System with MediTray Products is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2026-06-03 under 510(k) number K252854. 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 SteriTite Container System with MediTray Products?

SteriTite Container System with MediTray Products is a medical device that received FDA 510(k) clearance on 2026-06-03. The listed applicant is Case Medical, Inc.. The 510(k) number is K252854.

When did SteriTite Container System with MediTray Products receive FDA 510(k) clearance?

SteriTite Container System with MediTray Products received FDA 510(k) clearance on 2026-06-03, under 510(k) number K252854.

Who is the listed applicant for SteriTite Container System with MediTray Products?

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

What is the FDA product code for SteriTite Container System with MediTray Products?

The FDA product code for SteriTite Container System with MediTray Products is KCT.

其他以 Case Medical, 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。

K221492醫用設備規範文本翻譯： SteriTite容器系統搭配MediTray零件 K212711SteriTite容器系統搭配MediTray產品 K173259Case醫療用SteriTite可重用硬質消毒容器系統，配備MediTray配件 K161415SteriTite容器系統與MediTray產品

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 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.K251614不鏽鋼外科工具組Dentsply Sirona, Inc.

官方來源

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