Natrelle 133S Tissue Expander (K182054) - FDA 510(k) Clearance

K182054 is an FDA 510(k) clearance for the Natrelle 133S Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan (Irvine, US). The FDA issued a Cleared decision on August 29, 2018 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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