SteriBest® 消毒托盘系统
K号: K253187 · 2026-06-18
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决定日期2026-06-18
产品代码KCT
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
SteriBest® Sterilization Tray System is the device name listed in this FDA 510(k) record. The listed applicant is Mastel Surgical. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253187. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SteriBest® Sterilization Tray System?
SteriBest® Sterilization Tray System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Mastel Surgical. The 510(k) number is K253187.
When did SteriBest® Sterilization Tray System receive FDA 510(k) clearance?
SteriBest® Sterilization Tray System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253187.
Who is the listed applicant for SteriBest® Sterilization Tray System?
The FDA 510(k) record lists Mastel Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SteriBest® Sterilization Tray System?
The FDA product code for SteriBest® Sterilization Tray System is KCT.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：KCT）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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