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FDA 510(k)

Parietene™ Flat Sheet Mesh

K-Number: K253125 · 2025-10-24

ApplicantMedtronic - Sofradim Production
Decision Date2025-10-24
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Parietene™ Flat Sheet Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic - Sofradim Production. It received FDA 510(k) clearance on 2025-10-24 under 510(k) number K253125. 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 Parietene™ Flat Sheet Mesh?

Parietene™ Flat Sheet Mesh is a medical device that received FDA 510(k) clearance on 2025-10-24. The listed applicant is Medtronic - Sofradim Production. The 510(k) number is K253125.

When did Parietene™ Flat Sheet Mesh receive FDA 510(k) clearance?

Parietene™ Flat Sheet Mesh received FDA 510(k) clearance on 2025-10-24, under 510(k) number K253125.

Who is the listed applicant for Parietene™ Flat Sheet Mesh?

The FDA 510(k) record lists Medtronic - Sofradim Production as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Parietene™ Flat Sheet Mesh?

The FDA product code for Parietene™ Flat Sheet 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 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.K243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production

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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