Not Cleared Direct

DEN240038 - Oxiplex® (FDA 510(k) Clearance)

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

DEN240038 · Fziomed, Inc. · Orthopedic device
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Jun 2025
Decision
330d
Days
Class 2
Risk

DEN240038 is an FDA 510(k) submission (not cleared) for the Oxiplex®. Classified as Absorbable Gel For Intraoperative Use In Spine Surgery (product code QVL), Class II - Special Controls.

Submitted by Fziomed, Inc. (San Luis Obispo, US). The FDA issued a Not Cleared (DENG) decision on June 17, 2025 after a review of 330 days.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3047 - the FDA orthopedic device regulatory 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 330 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 Fziomed, Inc. devices

Submission Details

510(k) Number DEN240038 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 22, 2024
Decision Date June 17, 2025
Days to Decision 330 days
Submission Type Direct
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
208d slower than avg
Panel avg: 122d · This submission: 330d
Pathway characteristics

Device Classification

Product Code QVL Absorbable Gel For Intraoperative Use In Spine Surgery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3047
Definition This Device Is An Absorbable Gel Implant For Intraoperative Use In Spinal Procedures That Is Applied To Nerve Roots After Hemostasis Has Been Achieved And Prior To Closure. The Device Is Intended As An Adjunct To The Surgical Procedure To Reduce Pain And Neurological Symptoms.
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 Orthopedic devices follow this clearance model.

Regulatory Peers - QVL Absorbable Gel For Intraoperative Use In Spine Surgery

Devices cleared under the same product code (QVL) and FDA review panel - the closest regulatory comparables to DEN240038.
Oxiplex
K253326 · Fziomed, Inc. · May 2026