K150682 - CUSA Excel+ (FDA 510(k) Clearance)

K150682 is an FDA 510(k) clearance for the CUSA Excel+. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Lifesciences Corp. (Planisboro, US). The FDA issued a Cleared decision on December 18, 2015 after a review of 276 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.