FDA 510(k)

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K-번호: K260183 · 2026-05-24

결정일2026-05-24

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

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FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.

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기기 요약

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관련 임상시험

관련 기기 (코드: GCJ)

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