Bard Composite L/P Mesh
FDA 510(k) K061754 · Davol Inc., Sub. C. R. Bard, Inc.
510(k) numberK061754
Submission
- Device name
- Bard Composite L/P Mesh
- Applicant
- Davol Inc., Sub. C. R. Bard, Inc.
Canston, RI, US - Received
- June 21, 2006
- Decision date
- October 23, 2006
- 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 |
|---|---|---|
| K101851 | Ventralight ST MeshFTL · Special | 07/15/2010SE |
| K092032 | Bard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160FTL · Traditional | 12/08/2009SE |
| K081010 | Bard 3DMAX MeshFTL · Traditional | 10/07/2008SE |
| K061314 | Bard Extra Large Composix Kugel Hernia PatchFTL · Traditional | 06/02/2006SE |
| K051848 | Salute II Disposable Fixation Device, Models 0113070, 0113072, 0113073, 0113077, 0113079GDW · Traditional | 08/11/2005SE |
| K050610 | Salute Fixation SystemGDW · Traditional | 05/25/2005SE |
| K011069 | Aquasens Fluid Monitoring SystemHIG · Traditional | 08/16/2001SE |
| K003674 | Nezhat-Dorsey Reusable Electrosurgical Attachments: J-Hook Tip, L-Hook Tip, Corbitt…GEI · Traditional | 12/08/2000SE |
| K991799 | Davol Hysteroscopy Pouch Drape and Tubing Set, Model OoxxxxoHIG · Traditional | 09/13/1999SE |
| K991637 | Bard Sperma-Tex Preshaped Mesh (2.4X5.6), Model 0114700FTL · Traditional | 06/22/1999SE |
Questions and answers
When was Bard Composite L/P Mesh cleared by the FDA?
Bard Composite L/P Mesh (K061754) received a 510(k) decision of Substantially Equivalent on October 23, 2006, 124 days after the submission was received.
What is the product code of K061754?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.