Cleared Traditional

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

K894475 · Mentor Corp. · General & Plastic Surgery device
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Nov 1990
Decision
496d
Days
-
Risk

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.

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Submission Details

510(k) Number K894475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date November 26, 1990
Days to Decision 496 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
381d slower than avg
Panel avg: 115d · This submission: 496d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -