Duatene bilayer mesh
K-Number: K172395 · 2018-02-01
ApplicantSofradim Production
Decision Date2018-02-01
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Duatene bilayer mesh is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2018-02-01 under approval number K172395. 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 Duatene bilayer mesh?
Duatene bilayer mesh is a medical device that received FDA 510(k) clearance on 2018-02-01. It is manufactured by Sofradim Production. The 510(k) number is K172395.
When was Duatene bilayer mesh approved by the FDA?
Duatene bilayer mesh received FDA 510(k) clearance on 2018-02-01, under approval number K172395.
What company makes Duatene bilayer mesh?
Duatene bilayer mesh is manufactured by Sofradim Production.
What is the FDA product code for Duatene bilayer mesh?
The FDA product code for Duatene bilayer 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)
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
Related Devices (Code: FTL)
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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.