FDA 510(k)

MediBot 针筒驱动器 Uno

K号: K260183 · 2026-05-24

决定日期2026-05-24

产品代码GCJ

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决定实质等同

器械摘要

MediBot Needle Driver Uno is the device name listed in this FDA 510(k) record. The listed applicant is Parallel Robotics, LLC. It received FDA 510(k) clearance on 2026-05-24 under 510(k) number K260183. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MediBot Needle Driver Uno?

MediBot Needle Driver Uno is a medical device that received FDA 510(k) clearance on 2026-05-24. The listed applicant is Parallel Robotics, LLC. The 510(k) number is K260183.

When did MediBot Needle Driver Uno receive FDA 510(k) clearance?

MediBot Needle Driver Uno received FDA 510(k) clearance on 2026-05-24, under 510(k) number K260183.

Who is the listed applicant for MediBot Needle Driver Uno?

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

What is the FDA product code for MediBot Needle Driver Uno?

The FDA product code for MediBot Needle Driver Uno is GCJ.

相关器械（代码：GCJ）

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。

K262397CuratOR EX2742Eizo Corporation K260884UNIDRIVE选择系统Karl Storz SE & CO. KG K260972OEV-271MUH 液晶显示器；OEV-321MUH 液晶显示器；OEV-431MUH 液晶显示器Sony Corporation K261139VereSee（VER150、VER200、VER151、VER201、VER200C和VER-100-103）Freyja Healthcare, LLC K253541EZ-Close™（EZ Close 端口部位闭合装置，EZ Close MAX 端口部位闭合装置，EZ Close II 端口部位闭合装置）Medical Impact K261614LED液晶显示器（OEV-271H）Lg Electronics.Inc

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器械摘要

常见问题

相关临床试验

相关器械（代码：GCJ）

官方来源