DEN240038 is an FDA 510(k) submission for the Oxiplex®. This device is classified as a Absorbable Gel For Intraoperative Use In Spine Surgery (Class II - Special Controls, product code QVL).
Submitted by Fziomed, Inc. (San Luis Obispo, US). The FDA issued a Not Cleared (DENG) decision on June 17, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3047. 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..
| 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 | - |
| Product Code | QVL - Absorbable Gel For Intraoperative Use In Spine Surgery |
| Device Class | Class II - 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. |