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FDA 510(k)

Versius Surgical System (Versius Plus)

K-Number: K252111 · 2025-12-16

ApplicantCmr Surgical Limited
Decision Date2025-12-16
Product CodeSCV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Versius Surgical System (Versius Plus) is a medical device manufactured by Cmr Surgical Limited. It received FDA 510(k) clearance on 2025-12-16 under approval number K252111. The device is classified under product code SCV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Versius Surgical System (Versius Plus)?

Versius Surgical System (Versius Plus) is a medical device that received FDA 510(k) clearance on 2025-12-16. It is manufactured by Cmr Surgical Limited. The 510(k) number is K252111.

When was Versius Surgical System (Versius Plus) approved by the FDA?

Versius Surgical System (Versius Plus) received FDA 510(k) clearance on 2025-12-16, under approval number K252111.

What company makes Versius Surgical System (Versius Plus)?

Versius Surgical System (Versius Plus) is manufactured by Cmr Surgical Limited.

What is the FDA product code for Versius Surgical System (Versius Plus)?

The FDA product code for Versius Surgical System (Versius Plus) is SCV.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07613892 Post Operative Skin Approximation With Cyanoacrylate Based Wound Closure Adhesives COMPLETED NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_RECRUITING NCT07489820 Evaluation of the Efficacy of Negative Pressure Wound Therapy on Perineal Healing Following Abdominoperineal Amputation NOT_YET_RECRUITING

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: 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) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Cmr Surgical Limited

DEN230078Versius Surgical System

Related Devices (Code: SCV)

DEN230078Versius Surgical SystemCmr Surgical Limited K250725Hugo™ RAS SystemCovidien, LLC

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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