NQR · Sealant, Dural
· Class 3
Overview
| Product Code | NQR |
|---|---|
| Device Name | Sealant, Dural |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
Dural sealants are devices intended to aid in preventing cerebrospinal fluid leakage through suture-approximated dural wound edges. The sealant is sprayed or layered onto sutured dural wound edges and allowed to polymerize in place.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240027 | SpineSeal Spine Sealant | Pramand, LLC | Feb 14, 2025 | APPR |
| P220014 | CraniSeal Dural Sealant | Pramand, LLC | Jul 6, 2023 | APPR |
| P130014 | ADHERUS AUTOSPRAY DURAL SEALANT | Stryker Leibinger GmbH & Co KG | Mar 30, 2015 | APPR |
| P080013 | DURASEAL EXACT SPINE SEALANT SYSTEM | Integra LifeSciences Corporation | Sep 4, 2009 | APPR |
| P040034 | DURASEAL DURAL SEALANT SYSTEM | Integra LifeSciences Corporation | Apr 7, 2005 | APPR |
Top Applicants
- Integra LifeSciences Corporation — 2 clearances
- Pramand, LLC — 2 clearances
- Stryker Leibinger GmbH & Co KG — 1 clearance
