FDA 510(k)

Parietene Macroporous Mesh (PPM5050 )

K-Number: K250869 · 2025-04-23

Decision Date2025-04-23

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Parietene Macroporous Mesh (PPM5050 ) is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2025-04-23 under approval number K250869. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Parietene Macroporous Mesh (PPM5050 )?

Parietene Macroporous Mesh (PPM5050 ) is a medical device that received FDA 510(k) clearance on 2025-04-23. It is manufactured by Sofradim Production. The 510(k) number is K250869.

When was Parietene Macroporous Mesh (PPM5050 ) approved by the FDA?

Parietene Macroporous Mesh (PPM5050 ) received FDA 510(k) clearance on 2025-04-23, under approval number K250869.

What company makes Parietene Macroporous Mesh (PPM5050 )?

Parietene Macroporous Mesh (PPM5050 ) is manufactured by Sofradim Production.

What is the FDA product code for Parietene Macroporous Mesh (PPM5050 )?

The FDA product code for Parietene Macroporous Mesh (PPM5050 ) is FTL.

Other Devices by Sofradim Production

K163212Parietene DS Composite Mesh K173796Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) K172395Duatene bilayer mesh K192443Dextile Anatomical Mesh K223218Parietene Macroporous Mesh K220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

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Related Devices (Code: FTL)

K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) K153236Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlayC.R. Bard, Inc. K172089PROLENE Soft Polypropylene MeshETHICON, Inc. K170134Reperen Surgical MeshIconlab, Inc. K163212Parietene DS Composite MeshSofradim Production

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.