K894475 - MENTOR TISSUE EXPANDERS W/TDMAC COATING (FDA 510(k) Clearance)

K894475 is an FDA 510(k) clearance for the MENTOR TISSUE EXPANDERS W/TDMAC COATING. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Goleta, US). The FDA issued a Cleared decision on November 26, 1990 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Mentor Corp. devices