K000095 - OLYMPUS SONOSURG TROCAR XT3900 SYSTEM (FDA 510(k) Clearance)

K000095 is an FDA 510(k) clearance for the OLYMPUS SONOSURG TROCAR XT3900 SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 257 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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