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510(k) K251162

CUSA® Clarity Ultrasonic Surgical Aspirator System by Integra LifeSciences Corporation — Product Code LFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2025
Date Received
April 15, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ultrasonic Surgical
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Integra LifeSciences Corporation

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  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K221835 — CUSA Clarity Ultrasonic Surgical Aspirator System (August 22, 2022)
  • K221763 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 15, 2022)
  • K210128 — INTEGRA Wound Matrix (Macro-Channels) (October 8, 2021)
  • K210016 — Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot Syst (July 27, 2021)
  • K193346 — Codman Surgical Patties & Strips (November 20, 2020)
  • K201507 — Cadence Total Ankle System (June 29, 2020)
  • K200774 — CUSA Clarity Ultrasonic Surgical Aspirator System (June 23, 2020)

Other clearances for product code LFL

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  • K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (March 24, 2025)
  • K241700 — Tenex 2nd Generation System (November 18, 2024)
  • K240493 — CUSA® Clarity Ultrasonic Surgical Aspirator System (July 11, 2024)
  • K233036 — Ultrasonic Surgical System (June 18, 2024)
  • K230427 — CUSA Clarity Ultrasonic Surgical Aspirator System (July 11, 2023)
  • K231117 — neXus Ultrasonic Surgical Aspirator System (June 23, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)
  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)
  • K221102 — LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (December 15, 2022)