ProGrip Self-Gripping Polypropylene Mesh
K-Number: K243315 · 2025-01-17
ApplicantSofradim Production
Decision Date2025-01-17
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
ProGrip Self-Gripping Polypropylene Mesh is a medical device manufactured by Sofradim Production. It received FDA 510(k) clearance on 2025-01-17 under approval number K243315. 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 2025-01-17. It is manufactured by Sofradim Production. The 510(k) number is K243315.
When was ProGrip Self-Gripping Polypropylene Mesh approved by the FDA?
ProGrip Self-Gripping Polypropylene Mesh received FDA 510(k) clearance on 2025-01-17, under approval number K243315.
What company makes ProGrip Self-Gripping Polypropylene Mesh?
ProGrip Self-Gripping Polypropylene Mesh is manufactured by Sofradim Production.
What is the FDA product code for ProGrip Self-Gripping Polypropylene Mesh?
The FDA product code for ProGrip Self-Gripping Polypropylene Mesh is FTL.
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K172395Duatene bilayer mesh
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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.