K970471 - MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS) (FDA 510(k) Clearance)

K970471 is an FDA 510(k) clearance for the MENTOR ULTRASOUND ASSISTED TISSUE REMOVAL SYSTEM (TRS). Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on July 17, 1997 after a review of 160 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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