Cleared Traditional

CUSA Clarity Ultrasonic Surgical Aspirator System

K221835 · Integra LifeSciences Corporation · General & Plastic Surgery
Aug 2022
Decision
60d
Days
—
Risk

About This 510(k) Submission

K221835 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 August 22, 2022, 60 days after receiving the submission on June 23, 2022. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K221835 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2022
Decision Date August 22, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class —

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