Dextile Anatomical Mesh
FDA 510(k) K192443 · Sofradim Production
510(k) numberK192443
Submission
- Device name
- Dextile Anatomical Mesh
- Applicant
- Sofradim Production
Trévoux, FR - Received
- September 6, 2019
- Decision date
- December 6, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional | Sofradim Production | 05/21/2026SE |
| K253125 | Parietene Flat Sheet MeshFTL · Special | Medtronic - Sofradim Production | 10/24/2025SE |
| K251955 | Onflex MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 07/24/2025SE |
| K251557 | Bard® Mesh; Bard® Mesh Pre-ShapedFTL · Special | Davol, Inc. | 06/12/2025SE |
| K250869 | Parietene Macroporous Mesh (PPM5050 )FTL · Special | Sofradim Production | 04/23/2025SE |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-ShapedFTL · Traditional | Davol, Inc. | 04/09/2025SE |
| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/17/2025SE |
| K241250 | 3DMax Light MeshFTL · Special | Davol Inc., Subsidiary of C. R. Bard, Inc. | 06/14/2024SE |
| K232373 | Progrip Self-Gripping Polypropylene MeshFTL · Traditional | Sofradim Production | 01/18/2024SE |
| K233402 | Bard 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) | Device | Decision |
|---|---|---|
| K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)FTL · Traditional | 05/21/2026SE |
| K250869 | Parietene Macroporous Mesh (PPM5050 )FTL · Special | 04/23/2025SE |
| K243315 | ProGrip Self-Gripping Polypropylene MeshFTL · Traditional | 01/17/2025SE |
| K233661 | Transorb Self-Gripping Resorbable MeshOWT · Traditional | 02/13/2024SE |
| K232373 | Progrip Self-Gripping Polypropylene MeshFTL · Traditional | 01/18/2024SE |
| K223218 | Parietene Macroporous MeshFTL · Special | 12/02/2022SE |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D…FTL · Special | 06/22/2022SE |
| K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh)…FTL · Traditional | 03/09/2018SE |
| K172395 | Duatene bilayer meshFTL · Traditional | 02/01/2018SE |
| K163212 | Parietene DS Composite MeshFTL · Traditional | 06/29/2017SE |
Questions and answers
When was Dextile Anatomical Mesh cleared by the FDA?
Dextile Anatomical Mesh (K192443) received a 510(k) decision of Substantially Equivalent on December 6, 2019, 91 days after the submission was received.
What is the product code of K192443?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.