FDA product code QVL: Absorbable Gel For Intraoperative Use In Spine Surgery
QVL is the FDA product code for absorbable gel for intraoperative use in spine surgery. It is a Class II device, regulated under 21 CFR 888.3047 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under QVL, 1 in the last five years. The average 510(k) review took 213 days (median 213); 213 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Absorbable Gel For Intraoperative Use In Spine Surgery |
| Device class | Class II |
| Regulation | 21 CFR 888.3047 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QVL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 213 |
Top QVL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fziomed, Inc. | 1 | 2026-05-01 |
Most recent QVL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253326 | Fziomed, Inc. | Oxiplex | 2026-05-01 | 213 |
Recalls for QVL devices
openFDA lists no recalls for product code QVL.
Frequently asked questions
What is FDA product code QVL?
QVL is the FDA product code for absorbable gel for intraoperative use in spine surgery. It is a Class II device, regulated under 21 CFR 888.3047 and reviewed by the Orthopedic panel.
What device class is QVL?
Class II, regulation 21 CFR 888.3047. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVL?
Across 1 cleared submissions the average was 213 days from receipt to decision (median 213).
Which companies have the most QVL clearances?
Fziomed, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVL
- Run a recall and safety report across every QVL manufacturer
- Watch product code QVL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.