Identifiers
- 510(k) Number
- K151758 FDA 510(k)
- FDA Product Code
- GAT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.5000 FDA 510(k)
- Regulation Number
- 878.5000 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ALAR Nasal Valve Stent is an elliptically shaped fluoroplastic stent designed to support the lateral nasal wall. It features symmetrically spaced slits for bilateral nostril application and provides support and widening of the alar valve while cartilages scar into their new position.
The device is supplied as a single-use product and is approximately 20mm x 16mm in size. It is authorized under FDA 510(k) clearance with product code GAT and is intended to facilitate nasal breathing in patients with lateral nasal wall insufficiency.
Frequently asked questions
What is the ALAR Nasal Valve Stent designed for?
The ALAR Nasal Valve Stent is designed to support the lateral nasal wall, providing support and widening of the alar valve while cartilages scar into their new position to facilitate nasal breathing in patients with lateral nasal wall insufficiency.
How is the ALAR Nasal Valve Stent supplied?
The device is supplied as a single-use product and is approximately 20mm x 16mm in size, featuring symmetrically spaced slits for bilateral nostril application.
What is the regulatory status of the ALAR Nasal Valve Stent?
The ALAR Nasal Valve Stent is authorized under FDA 510(k) clearance with product code GAT, having been determined to be substantially equivalent to predicate devices.
Is the ALAR Nasal Valve Stent reusable?
No, the ALAR Nasal Valve Stent is supplied as a single-use product and should not be reused for patient safety and effectiveness reasons.
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: Effect of alar nasal valve stent on nasal breathing, DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ..., ALAR Nasal Valve Stent (K151758) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151758 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA 510(k) K151758 24 fields · synced Sep 19, 2026