Bard® Mesh; Bard® Mesh Pre-Shaped
K-Number: K251557 · 2025-06-12
ApplicantDavol, Inc.
Decision Date2025-06-12
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Bard® Mesh; Bard® Mesh Pre-Shaped is a medical device manufactured by Davol, Inc.. It received FDA 510(k) clearance on 2025-06-12 under approval number K251557. 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 Bard® Mesh; Bard® Mesh Pre-Shaped?
Bard® Mesh; Bard® Mesh Pre-Shaped is a medical device that received FDA 510(k) clearance on 2025-06-12. It is manufactured by Davol, Inc.. The 510(k) number is K251557.
When was Bard® Mesh; Bard® Mesh Pre-Shaped approved by the FDA?
Bard® Mesh; Bard® Mesh Pre-Shaped received FDA 510(k) clearance on 2025-06-12, under approval number K251557.
What company makes Bard® Mesh; Bard® Mesh Pre-Shaped?
Bard® Mesh; Bard® Mesh Pre-Shaped is manufactured by Davol, Inc..
What is the FDA product code for Bard® Mesh; Bard® Mesh Pre-Shaped?
The FDA product code for Bard® Mesh; Bard® Mesh Pre-Shaped 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.