K071669 - INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP (FDA 510(k) Clearance)

K071669 is an FDA 510(k) clearance for the INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Integra Radionics, Inc. (Burlington, US). The FDA issued a Cleared decision on August 17, 2007 after a review of 59 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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