Natrelle 133 Plus Tissue Expander (K143354) - FDA 510(k) Clearance

K143354 is an FDA 510(k) clearance for the Natrelle 133 Plus Tissue Expander. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on August 20, 2015 after a review of 269 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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