FDA 510(k)

Reperen Surgical Mesh

K-Number: K170134 · 2017-08-09

Decision Date2017-08-09

Product CodeFTL

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Reperen Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Iconlab, Inc.. It received FDA 510(k) clearance on 2017-08-09 under 510(k) 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. The listed applicant is Iconlab, Inc.. The 510(k) number is K170134.

When did Reperen Surgical Mesh receive FDA 510(k) clearance?

Reperen Surgical Mesh received FDA 510(k) clearance on 2017-08-09, under 510(k) number K170134.

Who is the listed applicant for Reperen Surgical Mesh?

The FDA 510(k) record lists Iconlab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reperen Surgical Mesh?

The FDA product code for Reperen Surgical Mesh is FTL.

Related Devices (Code: FTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.

Official Source

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