K894600 - CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR (FDA 510(k) Clearance)

K894600 is an FDA 510(k) clearance for the CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on January 19, 1990 after a review of 183 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 Valleylab, Inc. devices