QVL
- Product code
- QVL
- Device name
- Absorbable Gel For Intraoperative Use In Spine Surgery
- Device class
- Class 2
- 21 CFR
- 21 CFR 888.3047
- Medical specialty
- Orthopedic
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
FDA classification 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.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253326 | 2026-05-01 | Fziomed, Inc. | Oxiplex | |
| DEN240038 | 2025-06-17 | Fziomed, Inc. | Oxiplex® | — |
Official FDA classification page: QVL
Classification and pathway per current FDA publications. Data from openFDA (CC0).