T-Line® Hernia Mesh

FDA 510(k) K232924 · Deep Blue Medical Advances, Inc.

Substantially Equivalent

510(k) numberK232924

Submission

Device name
T-Line® Hernia Mesh
Applicant
Deep Blue Medical Advances, Inc.
Durham, NC, US
Received
September 19, 2023
Decision date
October 18, 2023
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
K251955Onflex™ MeshFTL · Special Davol Inc., Subsidiary of C. R. Bard, Inc.07/24/2025SE
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

More from Davol Inc., Subsidiary of C. R. Bard, Inc.

510(k)DeviceDecision
K230227T-Line Hernia MeshFTL · Special 02/23/2023SE
K221556T-Line Hernia MeshFTL · Traditional 11/28/2022SE
K193144T-Line Hernia MeshFTL · Traditional 03/30/2020SE

Questions and answers

When was T-Line® Hernia Mesh cleared by the FDA?

T-Line® Hernia Mesh (K232924) received a 510(k) decision of Substantially Equivalent on October 18, 2023, 29 days after the submission was received.

What is the product code of K232924?

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