K801042 - SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE (FDA 510(k) Clearance)

K801042 is an FDA 510(k) clearance for the SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Dow Corning Corp. Healthcare Industries Materials (Walker, US). The FDA issued a Cleared decision on June 26, 1980 after a review of 55 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.

View all Dow Corning Corp. Healthcare Industries Materials devices