ProGrip
ProGrip Self-Gripping Polypropylene Mesh is a surgical mesh intended to reinforce abdominal wall soft tissue where weakness exists. The FDA indication covers procedures involving inguinal…
ProGrip Self-Gripping Polypropylene Mesh is a surgical mesh intended to reinforce abdominal wall soft tissue where weakness exists. The FDA indication covers procedures involving inguinal and ventral hernia repair by an open approach.
The filing describes a non-absorbable knitted monofilament polypropylene textile with resorbable polylactic acid grips on one side. It says the mesh is available in different shapes and sizes and that the grips facilitate placement and positioning.
Listed Item
Self-Gripping Polypropylene Mesh Right Anatomical, Polypropylene with Polylactic Acid Grips
Mesh Construction
According to the filing, the mesh textile is designed for long-term soft-tissue reinforcement, while the grips contribute to fixation for at least eight weeks and are bioresorbable. The device is supplied sterile and intended for single use.
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) | K232373 |
| Record published | 2016-04-16 |
| Record revised | 2026-01-20 (version 13) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature up to 111 °F |
| Packaging | Case of 2 |
| Sizes | Width 8 to 30 cm; length 12 to 40 cm; height 12 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LPG1510AK2 | Length 15 cm | In distribution |
| LPG1612AL | Length 16 cm | In distribution |
| PP3020G | Width 20 cm | In distribution |
| TEM1208GL | Length 12 cm | In distribution |
| TEM1509G | Width 9 cm | In distribution |
| LPG1612AR | Length 16 cm | In distribution |
| PP4030G | Width 30 cm | In distribution |
| PP2015G | Width 15 cm | In distribution |
| TEM1515G | Width 15 cm | In distribution |
| ADG2015 | Width 15 cm | In distribution |
| PP1208DL | Width 8 cm | In distribution |
| ADG3020 | Length 30 cm | In distribution |
| TEM1409GL | Width 9 cm | In distribution |
| ADG4030 | Length 40 cm | In distribution |
| LPG1510AL | Length 15 cm | In distribution |
| LPG1614 | Width 14 cm | In distribution |
| TEM2015G | Length 20 cm | In distribution |
| TEM1208GR | Length 12 cm | In distribution |
| ADG1510 | Width 10 cm | In distribution |
| PP1515G | Width 15 cm | In distribution |
| TEM3015G | Width 15 cm | In distribution |
| LPG1309AR | Length 13 cm | In distribution |
| PP1509G | Length 15 cm | In distribution |
| PP3030G | Width 30 cm | In distribution |
| TEM1409GR | Length 14 cm | In distribution |
| LPG1510 | Length 15 cm | In distribution |
| LPG1510AR | Length 15 cm | In distribution |
| LPG1612 | Length 16 cm | In distribution |
| LPG1510X2 | Width 10 cm | In distribution |
| PP1208DR | Height 12 cm | In distribution |
| LPG1309AL | Length 13 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 |
| 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 |
| Bard | Davol Inc. | 27 |
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.