Surgipro
Multifilament Polypropylene Mesh
1manufacturer
16catalogue 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 | Covidien LP, United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| 510(k) | K982575 |
| Record published | 2015-09-02 |
| Record revised | 2026-03-16 (version 12) |
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 | Handling environment temperature up to 130 °F |
| Packaging | Case of 3, case of 2 |
| Sizes | Length 1 to 14 in; height 1 in |
| Distribution end date | 2026-04-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMPM-02 | In distribution | |
| SPMM-149 | Length 14 in | In distribution |
| SMPL-01 | In distribution | |
| SPM-35 | Length 3 in | In distribution |
| SPMM-66 | Length 6 in | Withdrawn |
| SPM-149 | Length 14 in | Withdrawn |
| SPM-35-W | Length 3 in | Withdrawn |
| SPM-149-W | Length 14 in | Withdrawn |
| SPM-66-W | Length 6 in | Withdrawn |
| SPMM-14 | Length 1 in | Withdrawn |
| SMHP-02 | Withdrawn | |
| SPMM-24 | Length 2 in | Withdrawn |
| SPMM-46 | Length 4 in | Withdrawn |
| SMHP-01 | Withdrawn | |
| SPM-14-W | Height 1 in | Withdrawn |
| SPMM-35 | Length 3 in | Withdrawn |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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Covidien | 510(k) number | 2010-12-15 | Not classified | Packaging process control | Sterility compromised due to breach in sterile barrier | 132 units | 2013-01-10 |
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.