Not Cleared Post-NSE

DEN090005 - PRINEO SKIN CLOSURE SYSTEM (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN090005 · Closure Medical Corp. · General & Plastic Surgery device
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Apr 2010
Decision
402d
Days
Class 2
Risk

DEN090005 is an FDA 510(k) submission (not cleared) for the PRINEO SKIN CLOSURE SYSTEM. Classified as Cutaneous Tissue Adhesive With Mesh (product code OMD), Class II - Special Controls.

Submitted by Closure Medical Corp. (Raleigh, US). The FDA issued a Not Cleared (DENG) decision on April 30, 2010 after a review of 402 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4011 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 402 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Closure Medical Corp. devices

Submission Details

510(k) Number DEN090005 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 24, 2009
Decision Date April 30, 2010
Days to Decision 402 days
Submission Type Post-NSE
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 114d · This submission: 402d
Pathway characteristics

Device Classification

Product Code OMD Cutaneous Tissue Adhesive With Mesh
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4011
Definition For Topical Application Only To Hold Closed Easily Approximated Skin Edges Of Wounds Such As Wounds From Surgical Incisions, Including Punctures From Minimally Invasive Surgery, And Simple Thorough Cleansed, Trauma-induced Lacerations. The Device May Be Used In Conjunction With, But Not In Place Of, Deep Dermal Sutures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.