K971580 - UAS ULTRASONIC ASPIRATOR SYSTEM (FDA 510(k) Clearance)

K971580 is an FDA 510(k) clearance for the UAS ULTRASONIC ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 9, 1997 after a review of 223 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.

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