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FDA 510(k)

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

K号: K261992 · 2026-09-25

申请人Solventum US, LLC
决定日期2026-09-25
产品代码JOJ
咨询委员会HO
决定Substantially Equivalent

器械摘要

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is the device name listed in this FDA 510(k) record. The listed applicant is Solventum US, LLC. It received FDA 510(k) clearance on 2026-09-25 under 510(k) number K261992. 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 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Solventum US, LLC. The 510(k) number is K261992.

When did 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) receive FDA 510(k) clearance?

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) received FDA 510(k) clearance on 2026-09-25, under 510(k) number K261992.

Who is the listed applicant for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

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

What is the FDA product code for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)?

The FDA product code for 3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) is JOJ.

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。

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Solventum US, LLC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。

K251866Tegaderm 术后透明抗菌敷料

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。

K260181LF 蒸汽灭菌过程指示胶带Intertape Polymer GroupK251991SafeSecure 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 ResearchK251048Rapicide PA 高级消毒测试条 模型参考号 = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge Company)

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