Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Parietene™ Macroporous Mesh (PPM5050 )

K-Number: K250869 · 2025-04-23

ApplicantSofradim Production
Decision Date2025-04-23
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Parietene™ Macroporous Mesh (PPM5050 ) is the device name listed in this FDA 510(k) record. The listed applicant is Sofradim Production. It received FDA 510(k) clearance on 2025-04-23 under 510(k) number K250869. 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™ Macroporous Mesh (PPM5050 )?

Parietene™ Macroporous Mesh (PPM5050 ) is a medical device that received FDA 510(k) clearance on 2025-04-23. The listed applicant is Sofradim Production. The 510(k) number is K250869.

When did Parietene™ Macroporous Mesh (PPM5050 ) receive FDA 510(k) clearance?

Parietene™ Macroporous Mesh (PPM5050 ) received FDA 510(k) clearance on 2025-04-23, under 510(k) number K250869.

Who is the listed applicant for Parietene™ Macroporous Mesh (PPM5050 )?

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

What is the FDA product code for Parietene™ Macroporous Mesh (PPM5050 )?

The FDA product code for Parietene™ Macroporous Mesh (PPM5050 ) is FTL.

Other records listing Sofradim Production 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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)K243315ProGrip™ Self-Gripping Polypropylene MeshK233661Transorb™ Self-Gripping Resorbable MeshK232373Progrip™ Self-Gripping Polypropylene MeshK223218Parietene Macroporous MeshK220586Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

View all 11 devices →

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.K250098Bard 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.

↑