K921251 - CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR (FDA 510(k) Clearance)

K921251 is an FDA 510(k) clearance for the CUSA SYSTEM 200C AND 200T ULTRASONIC ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on June 12, 1992 after a review of 88 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.

View all Valleylab, Inc. devices