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FDA 510(k)

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

K-Number: K250098 · 2025-04-09

ApplicantDavol, Inc.
Decision Date2025-04-09
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is a medical device manufactured by Davol, Inc.. It received FDA 510(k) clearance on 2025-04-09 under approval number K250098. 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 Soft Mesh; Bard Soft Mesh Pre-Shaped?

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is a medical device that received FDA 510(k) clearance on 2025-04-09. It is manufactured by Davol, Inc.. The 510(k) number is K250098.

When was Bard Soft Mesh; Bard Soft Mesh Pre-Shaped approved by the FDA?

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped received FDA 510(k) clearance on 2025-04-09, under approval number K250098.

What company makes Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is manufactured by Davol, Inc..

What is the FDA product code for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

The FDA product code for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped is FTL.

Other Devices by Davol, Inc.

K251557Bard® Mesh; Bard® Mesh Pre-Shaped PMA P050038Agent, absorbable hemostatic, non-collagen based

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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.

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