K130813 - MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (FDA 510(k) Clearance)

K130813 is an FDA 510(k) clearance for the MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST.... Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on April 11, 2013 after a review of 17 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.

View all Mentor Corp. devices