Identifiers
- 510(k) Number
- K110110 FDA 510(k)
- FDA Product Code
- FTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Atrium CentriFX Mesh is a surgical mesh classified as a polymeric device under FDA category 21 CFR 878.3300. It is designed as a synthetic, implantable material intended to reinforce or support soft tissue, commonly used in hernia repair and plastic surgery procedures to provide structural integrity and promote tissue integration.
This device is supplied as a sterile, single-use implant and is intended for use in controlled surgical environments. It is categorized under the FDA’s Special 510(k) clearance pathway and is regulated under the General, Plastic Surgery advisory committee. The mesh is available in various sizes and configurations, as referenced by the associated FEI numbers, and must be handled and stored according to manufacturer guidelines to maintain sterility and integrity prior to implantation.
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: ATRIUM CENTRILFX MESH (K110110) — FDA 510 (k) | Innolitics, Atrium Centrilfx Mesh 510 (k) FDA Premarket Notification K110110 ATRIUM ..., PDF K110110 - Atrium Centrilfx Mesh, Atrium Centrilfx Mesh - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K110110 | Class II | Active |
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Manufacturer
- Manufacturer
- Atrium Medical Corporation
Sources (1)
- FDA 510(k) K110110 24 fields · synced Sep 18, 2026