FDA 510(k)

StaClear注射器（SC250AN）；StaClear注射器（SC250LS）；StaClear注射器（SC250LL）

K号: K251849 · 2025-11-21

决定日期2025-11-21

产品代码QLY

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

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is the device name listed in this FDA 510(k) record. The listed applicant is Staclear, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K251849. The device is classified under product code QLY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Staclear, Inc.. The 510(k) number is K251849.

When did StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) receive FDA 510(k) clearance?

StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) received FDA 510(k) clearance on 2025-11-21, under 510(k) number K251849.

Who is the listed applicant for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

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

What is the FDA product code for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL)?

The FDA product code for StaClear Syringe (SC250AN); StaClear Syringe (SC250LS); StaClear Syringe (SC250LL) is QLY.

列明Staclear, Inc.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。

K243936StaClear注射器（SC250AN）；StaClear注射器（SC250LS）；StaClear注射器（SC250LL）

相关器械（代码：QLY）

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。

K243322Altaviz Intravitreal SyringeAltaviz, LLC K243027一次性房水收集器（SnovoDAHC I-50，SnovoDAHC II-50，SnovoDAHC II-50-27，SnovoDAHC II-100-27）Hangzhou Sightnovo Medical Technology Co., Ltd.K243936StaClear注射器（SC250AN）；StaClear注射器（SC250LS）；StaClear注射器（SC250LL）Staclear, Inc.K243149Microliter 剂量注射器（9、20、25、37.5、50和100微升型号）Congruence Medical Solutions, LLC K230372维特杰克注射器Ocuject, LLC K200242StaClear注射器Tribofilm Research, Inc.

官方来源

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