K012028 - ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 (FDA 510(k) Clearance)

K012028 is an FDA 510(k) clearance for the ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on July 27, 2001 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. 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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