NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS (K102806) - FDA 510(k) Clearance

K102806 is an FDA 510(k) clearance for the NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan Medical (Goleta, US). The FDA issued a Cleared decision on January 5, 2011 after a review of 99 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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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