Reperen Surgical Mesh
K-Number: K170134 · 2017-08-09
ApplicantIconlab, Inc.
Decision Date2017-08-09
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Reperen Surgical Mesh is a medical device manufactured by Iconlab, Inc.. It received FDA 510(k) clearance on 2017-08-09 under approval number K170134. 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 Reperen Surgical Mesh?
Reperen Surgical Mesh is a medical device that received FDA 510(k) clearance on 2017-08-09. It is manufactured by Iconlab, Inc.. The 510(k) number is K170134.
When was Reperen Surgical Mesh approved by the FDA?
Reperen Surgical Mesh received FDA 510(k) clearance on 2017-08-09, under approval number K170134.
What company makes Reperen Surgical Mesh?
Reperen Surgical Mesh is manufactured by Iconlab, Inc..
What is the FDA product code for Reperen Surgical Mesh?
The FDA product code for Reperen Surgical Mesh is FTL.
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.
K163212Parietene DS Composite MeshSofradim Production
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.