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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 the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc.. It received FDA 510(k) clearance on 2025-04-09 under 510(k) 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. The listed applicant is Davol, Inc.. The 510(k) number is K250098.

When did Bard Soft Mesh; Bard Soft Mesh Pre-Shaped receive FDA 510(k) clearance?

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

Who is the listed applicant for Bard Soft Mesh; Bard Soft Mesh Pre-Shaped?

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

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 records listing Davol, Inc. as applicant

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.

PMA P050038Agent, absorbable hemostatic, non-collagen basedK251557Bard® Mesh; Bard® Mesh Pre-Shaped

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 ProductionK243315ProGrip™ Self-Gripping Polypropylene MeshSofradim Production

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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