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FDA 510(k)

Onflex™ Mesh

K-Number: K251955 · 2025-07-24

ApplicantDavol Inc., Subsidiary of C. R. Bard, Inc.
Decision Date2025-07-24
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Onflex™ Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. It received FDA 510(k) clearance on 2025-07-24 under 510(k) number K251955. 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 Onflex™ Mesh?

Onflex™ Mesh is a medical device that received FDA 510(k) clearance on 2025-07-24. The listed applicant is Davol Inc., Subsidiary of C. R. Bard, Inc.. The 510(k) number is K251955.

When did Onflex™ Mesh receive FDA 510(k) clearance?

Onflex™ Mesh received FDA 510(k) clearance on 2025-07-24, under 510(k) number K251955.

Who is the listed applicant for Onflex™ Mesh?

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

What is the FDA product code for Onflex™ Mesh?

The FDA product code for Onflex™ Mesh is FTL.

Other records listing Davol Inc., Subsidiary of C. R. Bard, 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.

K2412503DMax Light MeshK233402Bard 3DMax MeshK191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

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 ProductionK251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, Inc.K243315ProGrip™ 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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