Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

QVL

Absorbable Gel For Intraoperative Use In Spine Surgery

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
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-01.

NumberDecision dateApplicantDevice nameSummary
K2533262026-05-01Fziomed, Inc.OxiplexPDF
DEN2400382025-06-17Fziomed, Inc.Oxiplex®—

1 summaries are archived here for direct download.

Official FDA classification page: QVL
Classification and pathway per current FDA publications. Data from openFDA (CC0).