K070313 - MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (FDA 510(k) Clearance)

K070313 is an FDA 510(k) clearance for the MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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