K011500 - MENTOR CONTOUR PROFILE TISSUE EXPANDER (FDA 510(k) Clearance)

K011500 is an FDA 510(k) clearance for the MENTOR CONTOUR PROFILE TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Mentor Corp. (Santa Barbara, US). The FDA issued a Cleared decision on December 3, 2001 after a review of 201 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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