K182335 - CPX 4 Breast Tissue Expander with Smooth Surface (FDA 510(k) Clearance)

K182335 is an FDA 510(k) clearance for the CPX 4 Breast Tissue Expander 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 September 25, 2018 after a review of 28 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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