Macropore Surgi-Wrap Mast Bioresorbable Sheet
FDA 510(k) K031955 · Macropore Biosurgery, Inc.
510(k) numberK031955
Submission
- Device name
- Macropore Surgi-Wrap Mast Bioresorbable Sheet
- Applicant
- Macropore Biosurgery, Inc.
San Diego, CA, US - Received
- June 25, 2003
- Decision date
- September 22, 2003
- 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 |
|---|---|---|
| K042261 | Macropore Puricel Lipoplasty SystemQPB · Traditional | 09/20/2004SE |
| K041105 | Macropore Hydrosorb Spine SystemKWQ · Traditional | 07/28/2004SE |
| K031785 | Macropore Cardio-Wrap (TS)OMH · Traditional | 09/04/2003SE |
| K024169 | Macropore Os ReconstructionEZX · Traditional | 07/01/2003SE |
| K023643 | Macropore Surgical Barrier FilmMTZ · Traditional | 02/21/2003SE |
| K021164 | Macropore Os TraumaHRS · Traditional | 07/01/2002SE |
| K012025 | Macropore Surgiwrap (TS)FTL · Traditional | 12/03/2001SE |
| K012769 | Macropore ENT Reconstruction FilmNHB · Traditional | 10/25/2001SE |
| K012413 | Macropore FX, PS, NS, LPJEY · Traditional | 09/18/2001SE |
| K011715 | Macropore Ib Resorbable PlugJDI · Traditional | 08/27/2001SESU |
Questions and answers
When was Macropore Surgi-Wrap Mast Bioresorbable Sheet cleared by the FDA?
Macropore Surgi-Wrap Mast Bioresorbable Sheet (K031955) received a 510(k) decision of Substantially Equivalent on September 22, 2003, 89 days after the submission was received.
What is the product code of K031955?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.