Parietex Composite PCO-OS and PCO-OB Meshes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K050187 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 Parietex Composite PCO-OS and PCO-OB Meshes are surgical meshes used during open (laparotomy) procedures or during laparoscopic procedures. The meshes are made from polyethylene terephthalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film separates the coated side of the mesh from surrounding tissues to minimize visceral attachment.
The Parietex Composite PCO-OS and PCO-OB Meshes are identical to the predicate PARIETEX COMPOSITE (PCO) meshes with the exception of the addition of a bi-dimensional textile flap to the current three-dimensional reinforcement on the PCO Mesh. The device is supplied as sterile and is for single use. It is regulated under FDA 510(k) clearance with product code FTL and regulation number 878.3300.
Frequently asked questions
What are Parietex Composite PCO-OS and PCO-OB Meshes used for?
These surgical meshes are designed for use during open (laparotomy) procedures or laparoscopic procedures. They feature a polyester material with a collagen-based hydrogel component that separates the coated side of the mesh from surrounding tissues to minimize visceral attachment.
How are Parietex Composite PCO-OS and PCO-OB Meshes supplied?
The meshes are supplied as sterile and are intended for single use only. They include a bi-dimensional textile flap added to the three-dimensional reinforcement found on the original PARIETEX COMPOSITE (PCO) meshes.
What is the regulatory status of Parietex Composite PCO-OS and PCO-OB Meshes?
The device is regulated under FDA 510(k) clearance with product code FTL and regulation number 878.3300. It has been determined to be substantially equivalent to predicate devices.
What materials are used in Parietex Composite PCO-OS and PCO-OB Meshes?
The meshes are constructed from polyethylene terephthalate (polyester) and incorporate a collagen-based hydrogel component. The hydrophilic collagen film helps separate the coated side of the mesh from surrounding tissues to minimize visceral attachment.
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: PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES (K050187) — FDA 510 (k ..., PDF K DrO (§7 - Food and Drug Administration, Parietex™ composite mesh - Medtronic
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K050187 | Class II | Active |
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Manufacturer
- Manufacturer
- Sofradim Production
Sources (1)
- FDA 510(k) K050187 24 fields · synced Sep 24, 2026