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FDA 510(k)

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH

K-Number: K043191 · 2005-05-16

ApplicantAngiologica B. M. Srl
Decision Date2005-05-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH is the device name listed in this FDA 510(k) record. The listed applicant is Angiologica B. M. Srl. It received FDA 510(k) clearance on 2005-05-16 under 510(k) number K043191. 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 REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH?

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH is a medical device that received FDA 510(k) clearance on 2005-05-16. The listed applicant is Angiologica B. M. Srl. The 510(k) number is K043191.

When did REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH receive FDA 510(k) clearance?

REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH received FDA 510(k) clearance on 2005-05-16, under 510(k) number K043191.

Who is the listed applicant for REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH?

The FDA 510(k) record lists Angiologica B. M. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH?

The FDA product code for REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS 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 Angiologica B. M. Srl 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.

K090432HEMORPEX SYSTEM

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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