Modification to Parietex Composite (PCO) Mesh
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K040998 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 Modification to Parietex Composite (PCO) Mesh is a surgical mesh made of polymeric material used for various medical applications. It is designed to provide support and reinforcement in surgical procedures.
This mesh is supplied as a single-use device and is not MRI safe. It is regulated under FDA 510(k) clearance with product code FTL and is classified as a class II device. The mesh is stored according to the manufacturer's specifications and is authorized for use in general and plastic surgery procedures.
Frequently asked questions
What is the Parietex Composite (PCO) Mesh used for?
The Parietex Composite (PCO) Mesh is a surgical mesh made of polymeric material designed to provide support and reinforcement in various surgical procedures, specifically in general and plastic surgery applications.
Is the Parietex Composite Mesh single-use or reusable?
The mesh is supplied as a single-use device and should not be reused for patient safety and regulatory compliance purposes.
What are the storage requirements for the PCO Mesh?
The mesh should be stored according to the manufacturer's specifications to maintain its integrity and effectiveness until use.
Is the Parietex Composite Mesh MRI safe?
No, the Parietex Composite (PCO) Mesh is not MRI safe, meaning it should not be used in patients undergoing MRI procedures.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040998 | Class II | Active |
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Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA 510(k) K040998 24 fields · synced Sep 23, 2026