StaClear注射器
K号: K200242 · 2020-07-27
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决定日期2020-07-27
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 is the device name listed in this FDA 510(k) record. The listed applicant is Tribofilm Research, Inc.. It received FDA 510(k) clearance on 2020-07-27 under 510(k) number K200242. 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?
StaClear Syringe is a medical device that received FDA 510(k) clearance on 2020-07-27. The listed applicant is Tribofilm Research, Inc.. The 510(k) number is K200242.
When did StaClear Syringe receive FDA 510(k) clearance?
StaClear Syringe received FDA 510(k) clearance on 2020-07-27, under 510(k) number K200242.
Who is the listed applicant for StaClear Syringe?
The FDA 510(k) record lists Tribofilm Research, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for StaClear Syringe?
The FDA product code for StaClear Syringe is QLY.
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：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。
K251849StaClear注射器（SC250AN）；StaClear注射器（SC250LS）；StaClear注射器（SC250LL）Staclear, Inc.K243322Altaviz Intravitreal SyringeAltaviz, LLCK243027一次性房水收集器（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, LLCK230372维特杰克注射器Ocuject, LLC
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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