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FDA 510(k)

Dynamis Robotic Surgical System

K-Number: K243326 · 2025-04-23

ApplicantLEM Surgical AG
Decision Date2025-04-23
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dynamis Robotic Surgical System is a medical device manufactured by LEM Surgical AG. It received FDA 510(k) clearance on 2025-04-23 under approval number K243326. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dynamis Robotic Surgical System?

Dynamis Robotic Surgical System is a medical device that received FDA 510(k) clearance on 2025-04-23. It is manufactured by LEM Surgical AG. The 510(k) number is K243326.

When was Dynamis Robotic Surgical System approved by the FDA?

Dynamis Robotic Surgical System received FDA 510(k) clearance on 2025-04-23, under approval number K243326.

What company makes Dynamis Robotic Surgical System?

Dynamis Robotic Surgical System is manufactured by LEM Surgical AG.

What is the FDA product code for Dynamis Robotic Surgical System?

The FDA product code for Dynamis Robotic Surgical System is OLO.

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 NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT05764954 A Study of Tumor-Treating Fields (TTFields) in People With Lung Adenocarcinoma ACTIVE_NOT_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: 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) PMID: 40902105 Design of Automatic Tool Replacement Mechanism for Laparoscopic Surgical Robot Arm for Solo Surgery. The international journal of medical robotics + computer assisted surgery : MRCAS (2025)

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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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