Cleared Special

CUSA Clarity Ultrasonic Surgical Aspirator System

K221763 · Integra LifeSciences Corporation · General & Plastic Surgery
Jul 2022
Decision
28d
Days
—
Risk

About This 510(k) Submission

K221763 is an FDA 510(k) clearance for the CUSA Clarity Ultrasonic Surgical Aspirator System, a Instrument, Ultrasonic Surgical, submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on July 15, 2022, 28 days after receiving the submission on June 17, 2022. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K221763 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2022
Decision Date July 15, 2022
Days to Decision 28 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class —

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