K221835 - CUSA Clarity Ultrasonic Surgical Aspirator System (FDA 510(k) Clearance)

K221835 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 August 22, 2022 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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