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FDA 510(k)

Parietene DS Composite Mesh

K-Number: K163212 · 2017-06-29

ApplicantSofradim Production
Decision Date2017-06-29
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Parietene DS Composite Mesh is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2017-06-29 under approval number K163212. 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 DS Composite Mesh?

Parietene DS Composite Mesh is a medical device that received FDA 510(k) clearance on 2017-06-29. It is manufactured by Sofradim Production. The 510(k) number is K163212.

When was Parietene DS Composite Mesh approved by the FDA?

Parietene DS Composite Mesh received FDA 510(k) clearance on 2017-06-29, under approval number K163212.

What company makes Parietene DS Composite Mesh?

Parietene DS Composite Mesh is manufactured by Sofradim Production.

What is the FDA product code for Parietene DS Composite Mesh?

The FDA product code for Parietene DS Composite Mesh is FTL.

Other Devices by Sofradim Production

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 K233661Transorb™ Self-Gripping Resorbable 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. K163576GORE SYNECOR Preperitoneal BiomaterialW. L. Gore & Associates, Inc.

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.

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