cCeLL - 在体
K号: K233391 · 2024-08-21
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决定日期2024-08-21
产品代码GWG
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
cCeLL - In vivo is the device name listed in this FDA 510(k) record. The listed applicant is VPIX Medical, Inc.. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K233391. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the cCeLL - In vivo?
cCeLL - In vivo is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is VPIX Medical, Inc.. The 510(k) number is K233391.
When did cCeLL - In vivo receive FDA 510(k) clearance?
cCeLL - In vivo received FDA 510(k) clearance on 2024-08-21, under 510(k) number K233391.
Who is the listed applicant for cCeLL - In vivo?
The FDA 510(k) record lists VPIX Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for cCeLL - In vivo?
The FDA product code for cCeLL - In vivo is GWG.
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。
列明VPIX Medical, 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。
相关器械（代码：GWG）
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。
K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro 灌洗系统Stryker InstrumentsK243429HJY VisualNext 3D 内窥镜视觉系统Hjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® 系统（ASX15/60）；AURORA® Surgiscope® 系统（ASX15/80）Integra LifeSciences CorporationK223615数字ClarusScope系统，数字NeuroPEN系统Clarus Medical, LLCK232618Aurora 手术显微镜系统Rebound Therapeutics Corporation
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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