FDA 510(k)

XACT ACE Robotic System

K-Number: K221116 · 2022-05-13

Decision Date2022-05-13

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XACT ACE Robotic System is a medical device manufactured by Xact Robotics, Ltd.. It received FDA 510(k) clearance on 2022-05-13 under approval number K221116. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XACT ACE Robotic System?

XACT ACE Robotic System is a medical device that received FDA 510(k) clearance on 2022-05-13. It is manufactured by Xact Robotics, Ltd.. The 510(k) number is K221116.

When was XACT ACE Robotic System approved by the FDA?

XACT ACE Robotic System received FDA 510(k) clearance on 2022-05-13, under approval number K221116.

What company makes XACT ACE Robotic System?

XACT ACE Robotic System is manufactured by Xact Robotics, Ltd..

What is the FDA product code for XACT ACE Robotic System?

The FDA product code for XACT ACE Robotic System is JAK.

Related Clinical Trials

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026)

Other Devices by Xact Robotics, Ltd.

K191332XACT Robotic System K201586XACT Robotic System K213759XACT Robotic System, ACE Model

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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.