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FDA 510(k)

ProGrip Self-Gripping Polypropylene Mesh

K-Number: K220540 · 2022-09-22

ApplicantCovidien
Decision Date2022-09-22
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ProGrip Self-Gripping Polypropylene Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-09-22 under 510(k) number K220540. 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 ProGrip Self-Gripping Polypropylene Mesh?

ProGrip Self-Gripping Polypropylene Mesh is a medical device that received FDA 510(k) clearance on 2022-09-22. The listed applicant is Covidien. The 510(k) number is K220540.

When did ProGrip Self-Gripping Polypropylene Mesh receive FDA 510(k) clearance?

ProGrip Self-Gripping Polypropylene Mesh received FDA 510(k) clearance on 2022-09-22, under 510(k) number K220540.

Who is the listed applicant for ProGrip Self-Gripping Polypropylene Mesh?

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

What is the FDA product code for ProGrip Self-Gripping Polypropylene Mesh?

The FDA product code for ProGrip Self-Gripping Polypropylene 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.

NCT07649434Effect of Biologic vs Synthetic Mesh on Chronic Pain After Laparoscopic Repair of Contralateral Asymptomatic Hernia in Patients With Unilateral Symptomatic Inguinal HerniaNOT_YET_RECRUITINGNCT05424484Mesh Augmented Reinforcement of Abdominal Wall Suture Line to Limit the Rate of Incisional Hernia OccurrenceACTIVE_NOT_RECRUITINGNCT06449378Transorb™ Self-Gripping Resorbable Mesh in High-risk Subjects Undergoing Open Repair of Ventral HerniaACTIVE_NOT_RECRUITING

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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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