Parietex
Plug and Patch System,Monofilament Polyester and Polylactic Acid Semi-Resorbable Plug with Monofilament Polyester Patch
1manufacturer
82catalogue numbers in this listing
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) | K220586 |
| Record published | 2015-10-06 |
| Record revised | 2025-08-18 (version 15) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: ; |
| Packaging | Case of 3, pack_or_inner_pack of 3 |
| Sizes | Length 8 to 50 cm; width 6 to 50 cm; outer diameter 4.6 to 20 cm |
| Distribution end date | 2026-06-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TECT1510AL | Width 10 cm | In distribution |
| TECR3030 | Length 30 cm | In distribution |
| TECT1510ADP2R | Length 15 cm | In distribution |
| PCO3020OSX | Length 25 cm | In distribution |
| PCO2520OSX | Width 20 cm | In distribution |
| PCO12X | Outer Diameter 12 cm | In distribution |
| PCO2520X | Length 25 cm | In distribution |
| PCO20FX | Outer Diameter 20 cm | In distribution |
| PCO20X | Outer Diameter 20 cm | In distribution |
| PCO1510OSX | Length 15 cm | In distribution |
| PCO1510FX | Length 15 cm | In distribution |
| TEC3030 | Length 30 cm | In distribution |
| PCO4VP | Greatest diameter:4.6 CM; | In distribution |
| PCO8OSX | Outer Diameter 8 cm | In distribution |
| PCO4VP | Greatest diameter:4.6 CM; | In distribution |
| TECT1612AR | Width 12 cm | In distribution |
| PCO1510X | Width 10 cm | In distribution |
| PCO6VP | Greatest Diameter:6.6 CM; | In distribution |
| TECT1510ADP2L | Length 15 cm | In distribution |
| TET1515 | Width 15 cm | In distribution |
| PCO9FX | Outer Diameter 9 cm | In distribution |
| TECT1510AR | Width 10 cm | In distribution |
| TET1309 | Length 13 cm | In distribution |
| PCO2520FX | Width 20 cm | In distribution |
| PCO12FX | Outer Diameter 12 cm | In distribution |
| TECT1510ADPR | Length 15 cm | In distribution |
| PCO2015FX | Length 20 cm | In distribution |
| PCO15FX | Outer Diameter 15 cm | In distribution |
| PCO2015X | Length 20 cm | In distribution |
| PCO2H1 | Length 8 cm | In distribution |
| TET1309D | Length 13 cm | In distribution |
| TECT1612AL | Length 16 cm | In distribution |
| PCOPM15 | Outer Diameter 15 cm | In distribution |
| TECT1309AR | Width 9 cm | In distribution |
| PCO3020X | Length 30 cm | In distribution |
| PCO3020FX | Width 20 cm | In distribution |
| TEC1515 | Width 15 cm | In distribution |
| TEC1510 | Width 10 cm | In distribution |
| TECT1309AL | Width 9 cm | In distribution |
| PCO2015OSX | Length 20 cm | In distribution |
| TET2020 | Width 20 cm | In distribution |
| PCO15X | Outer Diameter 15 cm | In distribution |
| TECR1515 | Length 15 cm | In distribution |
| PCO6VP | Greatest Diameter:6.6 CM; | In distribution |
| PCO9X | Outer Diameter 9 cm | In distribution |
| TEC1410P5 | Width 10 cm | In distribution |
| TEC2020 | Length 20 cm | In distribution |
| TECT1510ADPL | Length 15 cm | In distribution |
| PCOPM15H50 | Outer Diameter 15 cm | In distribution |
| TET3030 | Length 30 cm | In distribution |
| PCOPM15H35 | Outer Diameter 15 cm | In distribution |
| TECR1510 | Length 15 cm | In distribution |
| TEC1309 | Length 13 cm | In distribution |
| TET1510 | Length 15 cm | In distribution |
| TCM1510X3 | Length 15 cm | Withdrawn |
| PNP8X3 | Outer Diameter 8 cm | Withdrawn |
| TCM1106X3 | Width 6 cm | Withdrawn |
| PNP6 | Outer Diameter 6 cm | Withdrawn |
| PCO3728FX | Width 28 cm | Withdrawn |
| TECR1510AL | Length 15 cm | Withdrawn |
| PNP6X3 | Outer Diameter 6 cm | Withdrawn |
| PCO2H4 | Width 8 cm | Withdrawn |
| TEC1410DP | Length 14 cm | Withdrawn |
| TCM2020X3 | Width 20 cm | Withdrawn |
| PCO8VP | Outer Diameter 8.6 cm | Withdrawn |
| PCOPM20 | Outer Diameter 20 cm | Withdrawn |
| TET5050 | Length 50 cm | Withdrawn |
| PCO2H3 | Length 9 cm | Withdrawn |
| TECT1612AFR | Length 16 cm | Withdrawn |
| TECR1410DP2 | Length 14 cm | Withdrawn |
| PCO8VP | Greatest Diameter:8.6 CM; | Withdrawn |
| PNP8 | Outer Diameter 8 cm | Withdrawn |
| TCM1515X3 | Length 15 cm | Withdrawn |
| TCM1510 | Length 15 cm | Withdrawn |
| TECR1510AR | Width 10 cm | Withdrawn |
| TCM4530 | Length 45 cm | Withdrawn |
| TCM1515 | Length 15 cm | Withdrawn |
| TCM1106 | Length 11 cm | Withdrawn |
| TCM3015 | Length 30 cm | Withdrawn |
| TCM3030 | Width 30 cm | Withdrawn |
| TCM2020 | Length 20 cm | Withdrawn |
| PCO3728X | Width 28 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Technical Products | Technical Products, Inc. | 143 |
| 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 |
| 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 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 | 2018-10-05 | Class II | Unknown/Undetermined by firm | The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure | 7333 | 2020-05-07 |
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.