Not Cleared Direct

DEN130016 - XSTAT (FDA 510(k) Clearance)

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

DEN130016 · Revmedx, Inc. · General & Plastic Surgery device
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Apr 2014
Decision
428d
Days
Class 2
Risk

DEN130016 is an FDA 510(k) submission (not cleared) for the XSTAT. Classified as Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use (product code PGZ), Class II - Special Controls.

Submitted by Revmedx, Inc. (Washington, US). The FDA issued a Not Cleared (DENG) decision on April 3, 2014 after a review of 428 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4452 - 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 428 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 Revmedx, Inc. devices

Submission Details

510(k) Number DEN130016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 30, 2013
Decision Date April 03, 2014
Days to Decision 428 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
314d slower than avg
Panel avg: 114d · This submission: 428d
Pathway characteristics

Device Classification

Product Code PGZ Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4452
Definition To Control Bleeding In Junctional, Non-compressible Wounds Until Surgical Care Is Acquired.
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.