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 a medical device manufactured by Davol Inc., Subsidiary of C. R. Bard, Inc.. It received FDA 510(k) clearance on 2025-07-24 under approval 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. It is manufactured by Davol Inc., Subsidiary of C. R. Bard, Inc.. The 510(k) number is K251955.

When was Onflex Mesh approved by the FDA?

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

What company makes Onflex Mesh?

Onflex Mesh is manufactured by Davol Inc., Subsidiary of C. R. Bard, Inc..

What is the FDA product code for Onflex Mesh?

The FDA product code for Onflex Mesh is FTL.

Other Devices by Davol Inc., Subsidiary of C. R. Bard, Inc.

K233402Bard 3DMax Mesh K2412503DMax Light Mesh

Related Devices (Code: FTL)

K161550DynaMesh-VENTRALFeg Textiltechnik Forschungs- Und Entwicklungsgesellschaft K153632Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited) K153236Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlayC.R. Bard, Inc. K172089PROLENE Soft Polypropylene MeshETHICON, Inc. K170134Reperen Surgical MeshIconlab, Inc. K163212Parietene DS Composite 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.