K161176 - ARTOURA Breast Tissue Expanders with Smooth Surface (FDA 510(k) Clearance)

K161176 is an FDA 510(k) clearance for the ARTOURA Breast Tissue Expanders with Smooth Surface. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Worldwide, LLC (Irvin, US). The FDA issued a Cleared decision on May 23, 2016 after a review of 27 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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