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FDA 510(k)

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH

K-Number: K111121 · 2011-05-13

ApplicantProxy Biomedical , Ltd.
Decision Date2011-05-13
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH is the device name listed in this FDA 510(k) record. The listed applicant is Proxy Biomedical , Ltd.. It received FDA 510(k) clearance on 2011-05-13 under 510(k) number K111121. 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 VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH?

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH is a medical device that received FDA 510(k) clearance on 2011-05-13. The listed applicant is Proxy Biomedical , Ltd.. The 510(k) number is K111121.

When did VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH receive FDA 510(k) clearance?

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH received FDA 510(k) clearance on 2011-05-13, under 510(k) number K111121.

Who is the listed applicant for VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH?

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

What is the FDA product code for VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH?

The FDA product code for VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH is FTL.

Related Clinical Trials

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.

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Other records listing Proxy Biomedical , Ltd. as applicant

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.

K172636VitaMESH Macroporous PP Surgical MeshK060520VITAMESH MACROPOROUS PP SURGICAL MESHK052100MODIFICATION TO MOTIFMESH SOFT TISSUE PATCHK051245POLYFORM SYNTHETIC MESHK050678MOTIFMESH SOFT TISSUE PATCH

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 ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard 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.

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