K050885 - OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG (FDA 510(k) Clearance)

K050885 is an FDA 510(k) clearance for the OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Olympus Medical Systems Corporation (Melville, US). The FDA issued a Cleared decision on June 3, 2005 after a review of 57 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.

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