Identity
- Trade Name
- ADHERUS AUTOSPRAY DURAL SEALANT FDA PMA
- Generic Name
- Sealant, dural FDA PMA
Identifiers
- PMA Number
- P130014 FDA PMA
- FDA Product Code
- NQR FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Neurology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Adherus AutoSpray Dural Sealant is a dural sealant indicated for use in patients who are 13 years of age and older, as an adjunct to standard methods of dural repair, such as when using sutures, to provide watertight closure during cranial procedures. It is a neurology device used to provide a watertight closure. The device is manufactured by Stryker Leibinger GmbH & Co KG. The Adherus AutoSpray Dural Sealant is classified as a class 3 device.
The Adherus AutoSpray Dural Sealant is supplied with a specific set of instructions and is intended for use in a clinical setting. The device has received FDA PMA approval, with the PMA number being P130014. The device is also associated with the product code NQR and has a number of registration numbers, including 1424263 and 3035387162.
Frequently asked questions
What is the Adherus AutoSpray Dural Sealant used for?
The Adherus AutoSpray Dural Sealant is used as an adjunct to standard methods of dural repair, such as when using sutures, to provide watertight closure during cranial procedures in patients 13 years and older.
What type of device is the Adherus AutoSpray Dural Sealant?
The Adherus AutoSpray Dural Sealant is a dural sealant, classified as a class 3 device, and is used in neurology.
Has the Adherus AutoSpray Dural Sealant received FDA approval?
Yes, the Adherus AutoSpray Dural Sealant has received FDA PMA approval, with the PMA number being P130014.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: [PDF] Adherus - AutoSpray Dural Sealant - Stryker, Premarket Approval (PMA) - FDA, Adherus AutoSpray Dural Sealant, Adherus AutoSpray… - FDA.report, Premarket Approval (PMA) - FDA, Adherus AutoSpray ET Dural Sealant - P130014/S007 FDA PMA
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P130014 | Class III | Active |
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Manufacturer
- Manufacturer
- Stryker Leibinger Gmbh & Co. Kg
- FDA Applicant
- Stryker Leibinger GmbH & Co KG
Sources (1)
- FDA PMA P130014 24 fields · synced Sep 18, 2026