510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QVLClass II

Absorbable Gel For Intraoperative Use In Spine Surgery

21 CFR 888.3047 / Orthopedic
FDA source (opens on fda.gov)

QVL is the FDA product code for Absorbable Gel For Intraoperative Use In Spine Surgery, a class II device type, regulated under 21 CFR 888.3047. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QVL
Device name
Absorbable Gel For Intraoperative Use In Spine Surgery
FDA 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.
Regulation
21 CFR 888.3047
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QVL

By decision year
2 clearances under product code QVL with a decision year between 2025 and 2026, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QVL by decision year
YearClearances
20251
20261

Applicants with the most clearances

Product code QVL
Applicants holding the most 510(k) clearances under product code QVL
ApplicantClearances
Fziomed, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code