Vivosorb
3 catalogue numbers from 5x7 cm, listed by Polyganics Innovations B.V., under Mesh, Surgical, Polymeric. 1 manufacturer in China is registered for this product code.
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Suokang Medical Implants Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Polyganics Innovations B.V. |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| 510(k) | K042811 |
| Record published | 2015-09-21 |
| Record revised | 2025-08-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 4 °C |
| Sizes | Width 3 to 17 cm; length 2 to 12 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5×7 cm | Width 7 cm | In distribution |
| 2x3cm | Width 3 cm | In distribution |
| 12×17 cm | Width 17 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| Parietex | Sofradim Production | 82 |
| DynaMesh | FEG Textiltechnik Forschungs- und Entwicklungsges. mbH | 45 |
| Symbotex | Sofradim Production | 35 |
| Silicone Sheeting Reinforced | Bentec Medical OpCo, LLC. | 33 |
| Parietene | Sofradim Production | 32 |
| C-QUR | Atrium Medical Corporation | 31 |
| ProGrip | Sofradim Production | 31 |
| Silicone Sheeting Non-Reinforced | Bentec Medical OpCo, LLC. | 31 |
| Prolite | Atrium Medical Corporation | 31 |
| Gore Seamguard Bioabsorbable Staple Line Reinforce | W. L. Gore & Associates, Inc. | 30 |
| Surgimesh®wn | Aspide Medical | 28 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990028 | 2003-12-04 | FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT | Genzyme Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.