510(k) DEN240038
DEN240038 is an FDA 510(k) premarket notification submitted by Fziomed, Inc. for the device "Oxiplex®". The FDA issued a decision of De Novo Granted on Jun 17, 2025. The device falls under product code QVL (Absorbable Gel For Intraoperative Use In Spine Surgery), a Class II device regulated under 21 CFR 888.3047. Fziomed, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jun 17, 2025
- Date Received
- Jul 22, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorbable Gel For Intraoperative Use In Spine Surgery
- Device Class
- Class II
- Regulation Number
- 888.3047
- Review Panel
- OR
- Submission Type
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.