Data / Medical devices / France / Sofradim Production
Sofradim Production: FDA-registered device maker in TREVOUX Auvergne-Rhone-Alpes, France, 24 510(k) clearances
Sofradim Production is registered with the FDA (registration 9615742) in TREVOUX Auvergne-Rhone-Alpes, France. It lists 6 device types. The FDA files 24 510(k) clearances under its listings, the newest dated May 21, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615742
- FEI number
- 3003521774
- Address
- 116 Avenue Du Formans, TREVOUX Auvergne-Rhone-Alpes, France, 01600
- Owner or operator
- Covidien llc (1282497)
- Roles
- Manufacturer
- First device listed
- October 14, 2010
- Registered through
- 2026
- Brand names listed
- Dextile Anatomical Mesh, ENDURAGen Collagen Implant, ParieteneTM Macroporous Mesh, Parietene DS Composite Mesh, Parietene Flat Sheet Mesh, Parietene Macroporous Mesh, Parietex 2D 3D Anatomical Mesh, Parietex 2D 3D Anatomical Mesh and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Absorbable, Abdominal Hernia | OWT | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Large Abdominal Wall Defects | OXK | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects | OXJ | 2 | Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Polymeric | FTL | 2 | Manufacturer | accessdata.fda.gov |
| Surgical Film | OOD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 24, 2025 | K253125 | Parietene Flat Sheet Mesh | FTL | Substantially Equivalent | Medtronic - Sofradim Production | accessdata.fda.gov |
| April 23, 2025 | K250869 | Parietene Macroporous Mesh (PPM5050 ) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| January 17, 2025 | K243315 | ProGrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| February 13, 2024 | K233661 | Transorb Self-Gripping Resorbable Mesh | OWT | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| January 18, 2024 | K232373 | Progrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| December 2, 2022 | K223218 | Parietene Macroporous Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| September 22, 2022 | K220540 | ProGrip Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| December 6, 2019 | K192443 | Dextile Anatomical Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| March 9, 2018 | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 29, 2017 | K163212 | Parietene DS Composite Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| May 26, 2015 | K150091 | Versatex Monofilament Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| March 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| November 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| October 17, 2014 | K142091 | PARIETENE MACROPOROUS MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| August 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| June 13, 2012 | K120506 | PARIETEX COMPOSITE VENTRAL PATCH | FTL | Substantially Equivalent | Sofradim Production | accessdata.fda.gov |
| May 18, 2012 | K120605 | PERMACOL SURGICAL IMPLANT | FTM | Substantially Equivalent | Covidien, LLC | accessdata.fda.gov |
| December 17, 2004 | K043366 | PERMACOL SURGICAL IMPLANT | FTL | Substantially Equivalent | Tissue Science Laboratories, Plc | accessdata.fda.gov |
| January 17, 2002 | K013625 | PERMACOL | FTM | Substantially Equivalent | Tissue Science Laboratories, Plc | accessdata.fda.gov |
| February 17, 2000 | K992556 | PERMACOL | FTL | Substantially Equivalent | Tissue Science Laboratories, Plc | accessdata.fda.gov |
| January 20, 1999 | K982532 | PARIETEX | FTL | Substantially Equivalent | Cogent | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 23, 2018 | 79662 | Class II | Terminated | Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other f | 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 Abdominis Muscle Release (TAR) procedures. | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Polymeric
- All makers of Surgical Film
- All makers of Mesh, Surgical, Absorbable, Abdominal Hernia
- All makers of Mesh, Surgical
- All makers of Mesh, Surgical, Collagen, Large Abdominal Wall Defects
- All makers of Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.