Not Cleared Post-NSE

DEN130004 - MOERAE SURGICAL MARKING PEN (FDA 510(k) Clearance)

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

DEN130004 · Moerae Matrix, Inc. · General & Plastic Surgery device
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Dec 2014
Decision
591d
Days
Class 2
Risk

DEN130004 is an FDA 510(k) submission (not cleared) for the MOERAE SURGICAL MARKING PEN. Classified as Internal Tissue Marker (product code PDW), Class II - Special Controls.

Submitted by Moerae Matrix, Inc. (North Brunswick, US). The FDA issued a Not Cleared (DENG) decision on December 18, 2014 after a review of 591 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4670 - 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 591 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 Moerae Matrix, Inc. devices

Submission Details

510(k) Number DEN130004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 06, 2013
Decision Date December 18, 2014
Days to Decision 591 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
477d slower than avg
Panel avg: 114d · This submission: 591d
Pathway characteristics

Device Classification

Product Code PDW Internal Tissue Marker
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4670
Definition An Internal Tissue Marker Is A Prescription Use Device That Is Intended For Use Prior To Or During General Surgical Procedures To Demarcate Selected Sites On Internal Tissues.
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.