EvoEndo 单次使用内窥镜系统
K号: K213606 · 2022-02-14
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决定日期2022-02-14
产品代码FDS
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
EvoEndo Single-Use Endoscopy System is the device name listed in this FDA 510(k) record. The listed applicant is EvoEndo, Inc.. It received FDA 510(k) clearance on 2022-02-14 under 510(k) number K213606. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the EvoEndo Single-Use Endoscopy System?
EvoEndo Single-Use Endoscopy System is a medical device that received FDA 510(k) clearance on 2022-02-14. The listed applicant is EvoEndo, Inc.. The 510(k) number is K213606.
When did EvoEndo Single-Use Endoscopy System receive FDA 510(k) clearance?
EvoEndo Single-Use Endoscopy System received FDA 510(k) clearance on 2022-02-14, under 510(k) number K213606.
Who is the listed applicant for EvoEndo Single-Use Endoscopy System?
The FDA 510(k) record lists EvoEndo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EvoEndo Single-Use Endoscopy System?
The FDA product code for EvoEndo Single-Use Endoscopy System is FDS.
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EvoEndo, 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：FDS）
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。
K261400Ambu® aScope™ Gastro；Ambu® aScope™ Gastro 大号Ambu A/SK260856一次性远端附件 D-201-13404Olympus Medical Systems CorporationK260824胃肠内窥镜 奥林巴斯 GIF-2T1500Olympus Medical Systems CorporationK253702直观内镜胃肠道系统（IG1000）Intuitive Surgical, Inc.K260573EvoEndo 单次使用内窥镜系统EvoEndo, Inc.K250550富士胶片内窥镜型号EG-S100XT和VS-1000显示单元Fujifilm 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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