FDA 510(k)

VERIFY® 化学指示剂，适用于SYSTEM 1E® 和 SYSTEM 1® 内窥镜液体化学灭菌剂处理系统

K号: K233654 · 2023-12-08

申请人Steris

决定日期2023-12-08

产品代码JOJ

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

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-12-08 under 510(k) number K233654. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a medical device that received FDA 510(k) clearance on 2023-12-08. The listed applicant is Steris. The 510(k) number is K233654.

When did VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems receive FDA 510(k) clearance?

VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems received FDA 510(k) clearance on 2023-12-08, under 510(k) number K233654.

Who is the listed applicant for VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

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

What is the FDA product code for VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems?

The FDA product code for VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is JOJ.

列明Steris为申报人的其他记录

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。

K251452Celerity 5 HP 生物指示剂（LCB052）；Celerity 5 HP 挑战包（LCB059）；Celerity 20 HP 生物指示剂（LCB044）；Celerity 20 HP 挑战包（LCB045）K242773Electro Lube NXT K242189CELERITY HP指示胶带（PCC077）K241344MetriCide™ OPA Plus溶液测试条 K241055Electro Lube NXT K240760CELERITY HP指示胶带

查看所有 19 个设备 →

相关器械（代码：JOJ）

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。

K2619923M™ Attest™ 蒸汽化学集成器（1243A、1243B、1243RE、1243RES）Solventum US, LLC K260181LF 蒸汽灭菌过程指示胶带Intertape Polymer Group K251991SafeSecure 蒸汽灭菌过程指示器（4012，4013，4014，4016）；SafeSecure 氢氧化过氧化物蒸汽灭菌过程指示器（4211，4212，4213）Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA 测试条Serim Research K251048Rapicide PA 高级消毒测试条模型参考号 = ML02-0118STERIS Corporation K243876验证蒸汽集成指示器STERIS Corporation

官方来源

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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。