Composix
Composix L/P Mesh with PS Echo PS Positioning System, 10.2" x 14.2" (26.1 cm x 36.2 cm), Rectangle
1manufacturer
17catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Davol Inc., United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| Record published | 2015-08-19 |
| Record revised | 2025-08-18 (version 7) |
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 |
| Sizes | Length 10.2 to 26.1 cm; width 15.2 to 36.2 cm; length 9.2 to 14.2 in; width 7.2 to 10.2 in; outer diameter 11.4 cm |
| Distribution end date | 2021-08-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0123790 | Length 17.8 cm | In distribution |
| 0123810 | Width 25.4 cm | In distribution |
| 0134114 | Length 26.1 cm | In distribution |
| 0134680 | Width 21.0 cm | In distribution |
| 0123460 | Length 10.2 cm | In distribution |
| 0123680 | Length 15.2 cm | In distribution |
| 0134610 | Width 26.1 cm | In distribution |
| 0134810 | Width 26.1 cm | In distribution |
| 0134790 | Width 23.5 cm | In distribution |
| 0134450 | Outer Diameter 11.4 cm | In distribution |
| 0134113 | Width 33.7 cm | In distribution |
| 0123114 | Width 35.6 cm | In distribution |
| 0123113 | Width 33.0 cm | In distribution |
| 0134460 | Width 15.9 cm | In distribution |
| 0144114 | Length 14.2 in | Withdrawn |
| 0144790 | Width 7.2 in | Withdrawn |
| 0144810 | Length 10.2 in | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251557 | 2025-06-12 |
| K250098 | 2025-04-09 |
| K003323 | 2001-01-22 |
| K792281 | 1979-11-27 |
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.