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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 the device name listed in this FDA 510(k) record. The listed applicant is Integra LifeSciences Corporation. It received FDA 510(k) clearance on 2025-10-08 under 510(k) 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. The listed applicant is Integra LifeSciences Corporation. The 510(k) number is K251162.

When did CUSA® Clarity Ultrasonic Surgical Aspirator System receive FDA 510(k) clearance?

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

Who is the listed applicant for CUSA® Clarity Ultrasonic Surgical Aspirator System?

The FDA 510(k) record lists Integra LifeSciences Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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Other records listing Integra LifeSciences Corporation as applicant

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PMA P850010Agent, absorbable hemostatic, collagen basedPMA P840062MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACIDPMA P810006Agent, absorbable hemostatic, collagen basedPMA P080013Sealant, duralPMA P040034Sealant, duralPMA P900033Dressing, wound and burn, interactive

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Related Devices (Code: LFL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261448neXus Ultrasonic Surgical Aspirator SystemMisonix, LLCK242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)Shanghai Saints Sages Surgical Co., Ltd.K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)Stryker InstrumentsK241700Tenex 2nd Generation SystemTrice Medical, Inc.K240493CUSA® Clarity Ultrasonic Surgical Aspirator SystemIntegra LifeSciences CorporationK233036Ultrasonic Surgical SystemHunan Handlike Minimally Invasive Surgery Co., Ltd.

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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