FDA 510(k)

POINT Kinguide 灵活机器人臂手术立体定向系统

K号: K252755 · 2026-01-23

决定日期2026-01-23

产品代码OLO

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决定实质等同

器械摘要

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is the device name listed in this FDA 510(k) record. The listed applicant is Point Robotics MedTech, Inc.. It received FDA 510(k) clearance on 2026-01-23 under 510(k) number K252755. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is a medical device that received FDA 510(k) clearance on 2026-01-23. The listed applicant is Point Robotics MedTech, Inc.. The 510(k) number is K252755.

When did POINT Kinguide Agile Robotic Arm Surgical Stereotactic System receive FDA 510(k) clearance?

POINT Kinguide Agile Robotic Arm Surgical Stereotactic System received FDA 510(k) clearance on 2026-01-23, under 510(k) number K252755.

Who is the listed applicant for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?

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

What is the FDA product code for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System?

The FDA product code for POINT Kinguide Agile Robotic Arm Surgical Stereotactic System is OLO.

列明Point Robotics MedTech, 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。

K252989“POINT” 金导灵巧混合导航系统；DRF配件套装 K241130“POINT” 金导灵巧混合导航系统（PSHF01-000）K230087“POINT” 君导敏捷混合导航系统 K220241“POINT” 金导机器人辅助手术系统

官方来源

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