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FDA 510(k)

MediBot Needle Driver Uno

K-Number: K260183 · 2026-05-24

ApplicantParallel Robotics, LLC
Decision Date2026-05-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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