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FDA 510(k)

XACT Robotic System, ACE Model

K-Number: K213759 · 2022-09-23

ApplicantXact Robotics, Ltd.
Decision Date2022-09-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XACT Robotic System, ACE Model is a medical device manufactured by Xact Robotics, Ltd.. It received FDA 510(k) clearance on 2022-09-23 under approval number K213759. 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 Robotic System, ACE Model?

XACT Robotic System, ACE Model is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Xact Robotics, Ltd.. The 510(k) number is K213759.

When was XACT Robotic System, ACE Model approved by the FDA?

XACT Robotic System, ACE Model received FDA 510(k) clearance on 2022-09-23, under approval number K213759.

What company makes XACT Robotic System, ACE Model?

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

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

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

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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) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Xact Robotics, Ltd.

K191332XACT Robotic System K201586XACT Robotic System K221116XACT ACE Robotic System

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Official Source

View on FDA Database →

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

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