Cleared Traditional

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

K011500 · Mentor Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
201d
Days
-
Risk

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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Submission Details

510(k) Number K011500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2001
Decision Date December 03, 2001
Days to Decision 201 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 115d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -