Cleared Traditional

LIFECELL TISSUE EXPANDER (K112534) - FDA 510(k) Clearance

K112534 · Lifecell Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Aug 2012
Decision
344d
Days
-
Risk

K112534 is an FDA 510(k) clearance for the LIFECELL TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Lifecell Corp. (Branchburg, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 344 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 K112534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2011
Decision Date August 10, 2012
Days to Decision 344 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
229d slower than avg
Panel avg: 115d · This submission: 344d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -