K081459 - CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (FDA 510(k) Clearance)

K081459 is an FDA 510(k) clearance for the CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 13, 2008 after a review of 82 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.

View all Integra Radionics, Inc. devices