Cleared Traditional

CUSA Clarity Ultrasonic Surgical Aspirator System

K200774 · Integra LifeSciences Corporation · Neurology
Jun 2020
Decision
90d
Days
—
Risk

About This 510(k) Submission

K200774 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 June 23, 2020, 90 days after receiving the submission on March 25, 2020. This device falls under the Neurology review panel.

Submission Details

510(k) Number K200774 FDA.gov
FDA Decision Cleared SESE
Date Received March 25, 2020
Decision Date June 23, 2020
Days to Decision 90 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class —

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