Surgimesh®wn
Non woven, non knitted reinforcement material made from polypropylene.
1manufacturer
28catalogue 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 | Aspide Medical, United States |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Record published | 2015-10-23 |
| Record revised | 2025-08-18 (version 8) |
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 | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight; Special storage condition: Store at room temperature |
| Packaging | Box of 5, cardbox of 5, bos of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T1415 | 14x15cm | In distribution |
| T1015-8 | 10x15cm | In distribution |
| T221510 | TONNEAU 22x15x10cm | In distribution |
| T221510-8 | TONNEAU 22x15x10cm | In distribution |
| T1518 | 15x18cm | In distribution |
| T1518-8SR | SELF 15x18cm | In distribution |
| T913S | OVOIDE FENTE 9x13cm | In distribution |
| T3030-8 | 30x30cm | In distribution |
| T510 | 5x10cm | In distribution |
| T1415-SR | SELF 14X15cm | In distribution |
| T1415-8 | 14x15cm | In distribution |
| T613-8S | 1/2 OVALE FENTE 6x13cm | In distribution |
| T1115 | OVOIDE 11x15cm | In distribution |
| T1116-8XD | 11x16cm | In distribution |
| T1014-8 | OVOIDE 10x14cm | In distribution |
| T1515B | ANATOMIQUE 15x15cm | In distribution |
| T1418-8XD | 14x18cm | In distribution |
| T913 | OVOIDE 9x13cm | In distribution |
| T1518-8 | 15x18cm | In distribution |
| T1115-8TW | TWIN 11x15cm | In distribution |
| T1415-8SR | 14cm x 15cm | In distribution |
| T613-8 | 1/2 OVALE 6x13cm | In distribution |
| T3030 | 30x30cm | In distribution |
| T1015 | 10x15cm | In distribution |
| TALFI-8 | ALFI 4.5x10cm | In distribution |
| T813-8T | OVALE FENTE 8x13cm | In distribution |
| T302012 | TONNEAU 30x20x12cm | In distribution |
| T1115-8 | OVOIDE 11x15cm | 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 |
| Bard | Davol Inc. | 27 |
Showing 12 of 148. All products under Mesh, Surgical, Polymeric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120025 | 2012-06-26 |
| K092233 | 2010-06-25 |
| K072974 | 2008-08-18 |
| K061445 | 2007-02-01 |
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.