Cleared Traditional

CUSA? Clarity Ultrasonic Surgical Aspirator System

K240493 · Integra LifeSciences Corporation · Obstetrics & Gynecology
Jul 2024
Decision
142d
Days
Risk

About This 510(k) Submission

K240493 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 11, 2024, 142 days after receiving the submission on February 20, 2024. This device falls under the Obstetrics & Gynecology review panel.

Submission Details

510(k) Number K240493 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2024
Decision Date July 11, 2024
Days to Decision 142 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code LFL — Instrument, Ultrasonic Surgical
Device Class

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