Cleared Traditional

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (K865056) - FDA 510(k) Clearance

K865056 · Cox-Uphuff Intl. · General & Plastic Surgery device
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May 1987
Decision
149d
Days
-
Risk

K865056 is an FDA 510(k) clearance for the CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER. Classified as Tissue Expander And Accessories (product code LCJ).

Submitted by Cox-Uphuff Intl. (Santa Barbara, US). The FDA issued a Cleared decision on May 22, 1987 after a review of 149 days - within the typical 510(k) review window.

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 K865056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1986
Decision Date May 22, 1987
Days to Decision 149 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
34d slower than avg
Panel avg: 115d · This submission: 149d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCJ Tissue Expander And Accessories
Device Class -