K931902 - CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS. (FDA 510(k) Clearance)

K931902 is an FDA 510(k) clearance for the CUSA SYSTEM 200C/T ULTRASONIC ASPIRATOR & ACCESS.. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on September 16, 1994 after a review of 515 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Valleylab, Inc. devices