Sepramesh, Model 5959-1214
FDA 510(k) K063739 · Genzyme Corporation
510(k) numberK063739
Submission
- Device name
- Sepramesh, Model 5959-1214
- Applicant
- Genzyme Corporation
Cambridge, MA, US - Received
- December 18, 2006
- Decision date
- January 17, 2007
- 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
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| 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 |
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| K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorNDY · Traditional | 05/15/2008SE |
| K061508 | Osom Influenza A&B TestPSZ · Traditional | 06/12/2006SE |
| K051244 | Genzyme Osom Influenza a & B TestPSZ · Traditional | 02/21/2006SE |
| K053066 | Sepramesh Ip Bioresorbable Coating/Permanent MeshFTL · Traditional | 12/19/2005SE |
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| K040241 | N-Geneous Wide Range CRP Reagent and Calibrator SetDCK · Traditional | 06/25/2004SE |
| K040868 | Sepramesh Ip Bioresorbable Barrier - Permanent MeshFTM · Traditional | 06/04/2004SE |
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Questions and answers
When was Sepramesh, Model 5959-1214 cleared by the FDA?
Sepramesh, Model 5959-1214 (K063739) received a 510(k) decision of Substantially Equivalent on January 17, 2007, 30 days after the submission was received.
What is the product code of K063739?
The FDA product code is FTL – Mesh, Surgical, Polymeric, a Class II (moderate risk) device regulated under 21 CFR 878.3300.