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510(k) K221835

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2022
Date Received
June 23, 2022
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

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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)
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  • K223770 — Sonopet 1Q 3 7cm 1Q Large (February 16, 2023)