# NQR · Sealant, Dural

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/NQR

## Overview

- **Product Code:** NQR
- **Device Name:** Sealant, Dural
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **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](/device/P240027.md) | SpineSeal Spine Sealant | Pramand, LLC | Feb 14, 2025 | APPR |
| [P220014](/device/P220014.md) | CraniSeal Dural Sealant | Pramand, LLC | Jul 6, 2023 | APPR |
| [P130014](/device/P130014.md) | ADHERUS AUTOSPRAY DURAL SEALANT | Stryker Leibinger GmbH & Co KG | Mar 30, 2015 | APPR |
| [P080013](/device/P080013.md) | DURASEAL EXACT SPINE SEALANT SYSTEM | Integra LifeSciences Corporation | Sep 4, 2009 | APPR |
| [P040034](/device/P040034.md) | 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

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**Source:** [https://fda.innolitics.com/productcode/NQR](https://fda.innolitics.com/productcode/NQR)

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