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FDA 510(k)

CUSA® Clarity Ultrasonic Surgical Aspirator System

K-Number: K251162 · 2025-10-08

ApplicantIntegra LifeSciences Corporation
Decision Date2025-10-08
Product CodeLFL
DecisionSubstantially Equivalent

Device Summary

CUSA® Clarity Ultrasonic Surgical Aspirator System is a medical device manufactured by Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2025-10-08 under approval number K251162. The device is classified under product code LFL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSA® Clarity Ultrasonic Surgical Aspirator System?

CUSA® Clarity Ultrasonic Surgical Aspirator System is a medical device that received FDA 510(k) clearance on 2025-10-08. It is manufactured by Integra LifeSciences Corporation. The 510(k) number is K251162.

When was CUSA® Clarity Ultrasonic Surgical Aspirator System approved by the FDA?

CUSA® Clarity Ultrasonic Surgical Aspirator System received FDA 510(k) clearance on 2025-10-08, under approval number K251162.

What company makes CUSA® Clarity Ultrasonic Surgical Aspirator System?

CUSA® Clarity Ultrasonic Surgical Aspirator System is manufactured by Integra LifeSciences Corporation.

What is the FDA product code for CUSA® Clarity Ultrasonic Surgical Aspirator System?

The FDA product code for CUSA® Clarity Ultrasonic Surgical Aspirator 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: 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: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

Other Devices by Integra LifeSciences Corporation

K160811CRW STEREOTACTIC SYSTEM K161882CUSA Clarity Ultrasonic Surgical Aspirator System K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems K161189Integra TITAN Reverse Shoulder System K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory

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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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