Onflex™ Mesh

FDA 510(k) K251955 · Davol Inc., Subsidiary of C. R. Bard, Inc.

Substantially Equivalent

510(k) numberK251955

Submission

Device name
Onflex™ Mesh
Applicant
Davol Inc., Subsidiary of C. R. Bard, Inc.
Warwick, RI, US
Received
June 25, 2025
Decision date
July 24, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FTL – Mesh, Surgical, Polymeric
Device class
Class II (moderate risk)
Regulation
21 CFR 878.3300
Specialty
General, Plastic Surgery
Implant
Yes

Other 510(k)s with product code FTL

510(k)DeviceApplicantDecision
K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional Sofradim Production05/21/2026SE
K253125Parietene™ Flat Sheet MeshFTL · Special Medtronic - Sofradim Production10/24/2025SE
K251557Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special Davol, Inc.06/12/2025SE
K250869Parietene™ Macroporous Mesh (PPM5050 )FTL · Special Sofradim Production04/23/2025SE
K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional Davol, Inc.04/09/2025SE
K243315ProGrip™ Self-Gripping Polypropylene MeshFTL · Traditional Sofradim Production01/17/2025SE
K2412503DMax Light MeshFTL · Special Davol Inc., Subsidiary of C. R. Bard, Inc.06/14/2024SE
K232373Progrip™ Self-Gripping Polypropylene MeshFTL · Traditional Sofradim Production01/18/2024SE
K233402Bard 3DMax MeshFTL · Special Davol Inc., Subsidiary of C. R. Bard, Inc.11/01/2023SE
K232924T-Line® Hernia MeshFTL · Special Deep Blue Medical Advances, Inc.10/18/2023SE

More from Deep Blue Medical Advances, Inc.

510(k)DeviceDecision
K2412503DMax Light MeshFTL · Special 06/14/2024SE
K233402Bard 3DMax MeshFTL · Special 11/01/2023SE
K191287OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners…GDW · Special 07/16/2019SE

Questions and answers

When was Onflex™ Mesh cleared by the FDA?

Onflex™ Mesh (K251955) received a 510(k) decision of Substantially Equivalent on July 24, 2025, 29 days after the submission was received.

What is the product code of K251955?

The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.