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FDA 510(k)

Dextile Anatomical Mesh

K-Number: K192443 · 2019-12-06

ApplicantSofradim Production
Decision Date2019-12-06
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dextile Anatomical Mesh is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2019-12-06 under approval number K192443. 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 Dextile Anatomical Mesh?

Dextile Anatomical Mesh is a medical device that received FDA 510(k) clearance on 2019-12-06. It is manufactured by Sofradim Production. The 510(k) number is K192443.

When was Dextile Anatomical Mesh approved by the FDA?

Dextile Anatomical Mesh received FDA 510(k) clearance on 2019-12-06, under approval number K192443.

What company makes Dextile Anatomical Mesh?

Dextile Anatomical Mesh is manufactured by Sofradim Production.

What is the FDA product code for Dextile Anatomical Mesh?

The FDA product code for Dextile Anatomical Mesh 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 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. 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.

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