POREX(TM) TISSUE EXPANDER (K870154) - FDA 510(k) Clearance

K870154 is an FDA 510(k) clearance for the POREX(TM) TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Porex Medical (Fairburn, US). The FDA issued a Cleared decision on February 24, 1987 after a review of 42 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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