Parietene DS
Parietene DS is a composite mesh for reinforcing weak abdominal-wall tissue, including ventral hernia repairs. One side is a permanent, macroporous textile knitted from monofilament…
Parietene DS is a composite mesh for reinforcing weak abdominal-wall tissue, including ventral hernia repairs. One side is a permanent, macroporous textile knitted from monofilament polypropylene.
The opposite side has a fully absorbable synthetic film bonded to the textile fibers. The textile provides long-term reinforcement, while the film is designed to minimize tissue attachment when the mesh contacts abdominal viscera.
Listed Item
Composite Mesh Monofilament Polypropylene Mesh with Absorbable Synthetic Film and Marking
Placement Features
The mesh is designed for intraperitoneal placement through open or laparoscopic approaches. Violet marking helps with orientation and centering, and nonabsorbable sutures are pre-attached. The film contains a synthetic copolymer, while the binding agent and violet marking use absorbable polycaprolactone.
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) | K163212 |
| Record published | 2017-12-15 |
| Record revised | 2026-03-16 (version 17) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack_or_inner_pack of 3, case of 3 |
| Sizes | Width 15 to 35 cm; length 10 to 30 cm; outer diameter 12 to 15 cm |
| Distribution end date | 2026-03-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PPDS12 | Outer Diameter 12 cm | In distribution |
| PPDS2520 | Width 25 cm | In distribution |
| PPDS15 | Outer Diameter 15 cm | In distribution |
| PPDS3530 | Width 35 cm | In distribution |
| PPDS3530 | Width 35 cm | In distribution |
| PPDS2015 | Width 20 cm | In distribution |
| PPDS1510 | Width 15 cm | In distribution |
| PPDS15 | Outer Diameter 15 cm | In distribution |
| PPDS2520 | Length 20 cm | In distribution |
| PPDS2015 | Length 15 cm | In distribution |
| PPDS3020 | Length 20 cm | In distribution |
| PPDS1510 | Width 15 cm | In distribution |
| PPDS12 | Outer Diameter 12 cm | In distribution |
| PPDS3020 | Width 30 cm | In distribution |
| PPDS2015X3 | Width 20 cm | Withdrawn |
| PPDS1510X3 | Length 10 cm | Withdrawn |
| PPDS2015X3 | Width 20 cm | Withdrawn |
| PPDS15X3 | Outer Diameter 15 cm | Withdrawn |
| PPDS12X3 | Outer Diameter 12 cm | Withdrawn |
| PPDS12X3 | Outer Diameter 12 cm | Withdrawn |
| PPDS1510X3 | Length 10 cm | Withdrawn |
| PPDS15X3 | Outer Diameter 15 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.