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FDA 510(k)

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

K-Number: K103568 · 2010-12-22

ApplicantColoplast A/S
Decision Date2010-12-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2010-12-22 under 510(k) number K103568. 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 RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH?

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH is a medical device that received FDA 510(k) clearance on 2010-12-22. The listed applicant is Coloplast A/S. The 510(k) number is K103568.

When did RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH receive FDA 510(k) clearance?

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH received FDA 510(k) clearance on 2010-12-22, under 510(k) number K103568.

Who is the listed applicant for RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH?

The FDA product code for RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH is FTL.

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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

View on FDA Database →

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

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