K251162 - CUSA® Clarity Ultrasonic Surgical Aspirator System (FDA 510(k) Clearance)

K251162 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 October 8, 2025 after a review of 176 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Integra LifeSciences Corporation devices