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 a medical device manufactured by Medtronic - Sofradim Production. It received FDA 510(k) clearance on 2025-10-24 under approval 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. It is manufactured by Medtronic - Sofradim Production. The 510(k) number is K253125.
When was Parietene Flat Sheet Mesh approved by the FDA?
Parietene Flat Sheet Mesh received FDA 510(k) clearance on 2025-10-24, under approval number K253125.
What company makes Parietene Flat Sheet Mesh?
Parietene Flat Sheet Mesh is manufactured by Medtronic - Sofradim Production.
What is the FDA product code for Parietene Flat Sheet Mesh?
The FDA product code for Parietene Flat Sheet Mesh is FTL.
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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.