K840464 - TISSUE EXPANDER (FDA 510(k) Clearance)

K840464 is an FDA 510(k) clearance for the TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Surgitek (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 38 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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