ProSup
Pelvic Floor Repair Mesh,Polyester
1manufacturer
1catalogue number
36510(k) clearances naming this product code
1recall
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 | Sofradim Production, France |
|---|---|
| FDA product code | FTL |
| Device type | Mesh, Surgical, Polymeric |
| Device class | Class 2 |
| Regulation | 21 CFR 878.3300 |
| Establishment | Manufacturer |
| 510(k) | K982532 |
| Record published | 2015-10-06 |
| Record revised | 2024-05-16 (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 |
| Sizes | Height 4 cm; width 30 cm |
| Distribution end date | 2016-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TECG3004 | Height 4 cm | Withdrawn |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 |
|---|---|
| K253956 | 2026-05-21 |
| K250869 | 2025-04-23 |
| K243315 | 2025-01-17 |
| K232373 | 2024-01-18 |
| K223218 | 2022-12-02 |
| K220586 | 2022-06-22 |
| K192443 | 2019-12-06 |
| K173796 | 2018-03-09 |
| K172395 | 2018-02-01 |
| K163212 | 2017-06-29 |
| K150091 | 2015-05-26 |
| K143386 | 2015-03-13 |
| K142908 | 2014-11-14 |
| K142900 | 2014-10-28 |
| K142091 | 2014-10-17 |
| K140941 | 2014-05-07 |
| K131969 | 2013-08-22 |
| K123479 | 2012-12-11 |
| K120897 | 2012-06-29 |
| K120506 | 2012-06-13 |
| K110663 | 2011-08-11 |
| K110815 | 2011-04-19 |
| K110816 | 2011-04-19 |
| K103682 | 2011-03-04 |
| K101519 | 2010-11-05 |
| K101197 | 2010-05-05 |
| K090858 | 2009-05-06 |
| K081126 | 2008-08-13 |
| K081050 | 2008-05-28 |
| K073287 | 2008-03-13 |
| K071629 | 2007-07-10 |
| K050187 | 2005-02-18 |
| K040998 | 2004-04-29 |
| K033376 | 2004-01-15 |
| K003990 | 2001-01-24 |
| K991400 | 1999-07-12 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-02-23 | Class II | Other | There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device’s Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdomin | 703 | 2020-05-12 |
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.