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FDA 510(k)

MediBot針筒駕駛器一號

K 號:K260183 · 2026-05-24

決定日期2026-05-24
產品代碼GCJ
諮詢委員會GU
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械(代碼:GCJ)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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