Cleared Traditional

K240493 - CUSA® Clarity Ultrasonic Surgical Aspirator System (FDA 510(k) Clearance)

Jul 2024
Decision
142d
Days
Risk

K240493 is an FDA 510(k) clearance for the CUSA® Clarity Ultrasonic Surgical Aspirator System. This device is classified as 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 FDA review panel.

Submission Details

510(k) Number K240493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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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