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FDA 510(k)

Ultrasonic Surgical System

K-Number: K190281 · 2019-10-31

ApplicantMedisonic Technology CO
Decision Date2019-10-31
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

Ultrasonic Surgical System is a medical device manufactured by Medisonic Technology CO. It received FDA 510(k) clearance on 2019-10-31 under approval number K190281. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrasonic Surgical System?

Ultrasonic Surgical System is a medical device that received FDA 510(k) clearance on 2019-10-31. It is manufactured by Medisonic Technology CO. The 510(k) number is K190281.

When was Ultrasonic Surgical System approved by the FDA?

Ultrasonic Surgical System received FDA 510(k) clearance on 2019-10-31, under approval number K190281.

What company makes Ultrasonic Surgical System?

Ultrasonic Surgical System is manufactured by Medisonic Technology CO.

What is the FDA product code for Ultrasonic Surgical System?

The FDA product code for Ultrasonic Surgical System is LFL.

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 NCT07202312 Ozone-therapy in Non-surgical Periodontal Therapy COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION

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)

Related Devices (Code: LFL)

K161882CUSA Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences Corporation K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthEthicon Endo-Suregery, LLC K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC K151136HARMONIC HOOKEthicon Endo-Surgery, LLC K153299Tenex Health TX SystemTenex Health, Inc. K172691Ultrasonic GeneratorOlympus Medical Systems 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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