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FDA 510(k)

Magnetic Surgical System

K-Number: K252435 · 2025-09-26

ApplicantLevita Magnetics International Corp
Decision Date2025-09-26
Product CodePNL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Magnetic Surgical System is a medical device manufactured by Levita Magnetics International Corp. It received FDA 510(k) clearance on 2025-09-26 under approval number K252435. The device is classified under product code PNL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Magnetic Surgical System?

Magnetic Surgical System is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Levita Magnetics International Corp. The 510(k) number is K252435.

When was Magnetic Surgical System approved by the FDA?

Magnetic Surgical System received FDA 510(k) clearance on 2025-09-26, under approval number K252435.

What company makes Magnetic Surgical System?

Magnetic Surgical System is manufactured by Levita Magnetics International Corp.

What is the FDA product code for Magnetic Surgical System?

The FDA product code for Magnetic Surgical System is PNL.

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 NCT03331380 Technical Development of Cardiovascular Magnetic Resonance Imaging (CMR) Using a Low Specific Absorption Rate (SAR) Scanner System 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

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 Levita Magnetics International Corp

DEN150007Magnetic Surgical System K171429Magnetic Surgical System K180894Magnetic Surgical System K190006Magnetic Surgical System K191762Magnetic Surgical System K223673Surgeon Controlled Arm

View all 8 devices →

Related Devices (Code: PNL)

DEN150007Magnetic Surgical SystemLevita Magnetics International Corp K171429Magnetic Surgical SystemLevita Magnetics International Corp K180894Magnetic Surgical SystemLevita Magnetics International Corp K190006Magnetic Surgical SystemLevita Magnetics International Corp K191762Magnetic Surgical SystemLevita Magnetics International Corp K223673Surgeon Controlled ArmLevita Magnetics International Corp

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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