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

K240493 is an FDA 510(k) clearance for the CUSA® Clarity Ultrasonic Surgical Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on July 11, 2024 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

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