FDA 510(k)

EvoEndo 单次使用内窥镜系统

K号: K260573 · 2026-04-21

决定日期2026-04-21

产品代码FDS

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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 2026-04-21 under 510(k) number K260573. 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 2026-04-21. The listed applicant is EvoEndo, Inc.. The 510(k) number is K260573.

When did EvoEndo Single-Use Endoscopy System receive FDA 510(k) clearance?

EvoEndo Single-Use Endoscopy System received FDA 510(k) clearance on 2026-04-21, under 510(k) number K260573.

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.

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。

K251708EvoEndo 单次使用内窥镜系统 K250900EvoEndo 单次使用内窥镜系统 K213606EvoEndo 单次使用内窥镜系统

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/S K260824胃肠内窥镜奥林巴斯 GIF-2T1500Olympus Medical Systems Corporation K260856一次性远端附件 D-201-13404Olympus Medical Systems Corporation K253702直观内镜胃肠道系统（IG1000）Intuitive Surgical, Inc.K250550富士胶片内窥镜型号EG-S100XT和VS-1000显示单元Fujifilm Corporation K253568Hood DH-084STR；Hood DH-094STR；Hood DH-104STR；Hood DH-114STR；Hood DH-124STR；Hood DH-134STRFujifilm Corporation

官方来源

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