Sofradim Production
TREVOUX Auvergne-Rhone-Alpes, FR
SOFRADIM PRODUCTION appears in FDA device records in TREVOUX Auvergne-Rhone-Alpes, FR. FDA records list 42 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 42 510(k) clearances for Sofradim Production between 1999 and 2026. The busiest year on record is 2011, with 4. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2001 | 2 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 2 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 3 |
| 2013 | 1 |
| 2014 | 4 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2022 | 2 |
| 2024 | 2 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253956 | ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) | FTL | Substantially Equivalent | |
| K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | FTL | Substantially Equivalent | |
| K243315 | ProGrip™ Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | |
| K233661 | Transorb™ Self-Gripping Resorbable Mesh | OWT | Substantially Equivalent | |
| K232373 | Progrip™ Self-Gripping Polypropylene Mesh | FTL | Substantially Equivalent | |
| K223218 | Parietene Macroporous Mesh | FTL | Substantially Equivalent | |
| K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh | FTL | Substantially Equivalent | |
| K192443 | Dextile Anatomical Mesh | FTL | Substantially Equivalent | |
| 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 | |
| K172395 | Duatene bilayer mesh | FTL | Substantially Equivalent | |
| K163212 | Parietene DS Composite Mesh | FTL | Substantially Equivalent | |
| K150091 | Versatex Monofilament Mesh | FTL | Substantially Equivalent | |
| K143386 | Progrip Laparoscopic Self-Fixating Mesh | FTL | Substantially Equivalent | |
| 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 | |
| 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 | |
| K142091 | PARIETENE MACROPOROUS MESH | FTL | Substantially Equivalent | |
| K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH | FTL | Substantially Equivalent | |
| K131969 | SYMBOTEX(TM) COMPOSITE MESH | FTL | Substantially Equivalent | |
| K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH | FTL | Substantially Equivalent | |
| K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH | FTL | Substantially Equivalent | |
| K120506 | PARIETEX COMPOSITE VENTRAL PATCH | FTL | Substantially Equivalent | |
| K110663 | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) | FTL | Substantially Equivalent | |
| K110816 | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) | FTL | Substantially Equivalent | |
| K110815 | PARIETEX OPTIMIZED COMPOSTIE MESH | FTL | Substantially Equivalent | |
| K103682 | PARIETEX PROGRIP | FTL | Substantially Equivalent | |
| K101519 | PARIETEX PLUG AND PATCH | FTL | Substantially Equivalent | |
| K101197 | PARIE TENE PROGRIP MESH | FTL | Substantially Equivalent | |
| K090858 | PARIETEX MONOFILAMENT POLYESTER MESH | FTL | Substantially Equivalent | |
| K081126 | PARIETEX COMPOSITE MONO PM MESH | FTL | Substantially Equivalent | |
| K081050 | PARIETEX PROGRIP MESH | FTL | Substantially Equivalent | |
| K073287 | PREVADH MESH | FTL | Substantially Equivalent | |
| K072951 | PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES | OTP | Substantially Equivalent | |
| K071629 | PARIETEX POLYESTER MESH WITH INTRODUCER | FTL | Substantially Equivalent | |
| K051503 | UGYTEX SUAL KNIT MESH | OTP | Substantially Equivalent | |
| K050187 | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES | FTL | Substantially Equivalent | |
| K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | OTN | Substantially Equivalent | |
| K040998 | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH | FTL | Substantially Equivalent | |
| K033376 | UGYTEX MESH | FTL | Substantially Equivalent | |
| K032093 | PARIEFIX | GCJ | Substantially Equivalent | |
| K012949 | URETEX SUP PUBOURETHRAL SLING | OTN | Substantially Equivalent | |
| K003990 | SOFRADIM PARIETEX SURGICAL MESHES | FTL | Substantially Equivalent | |
| K991400 | PARIETENE POLYPROPYLENE MESH | FTL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615742 | 3003521774 | SOFRADIM PRODUCTION | 116 AVENUE DU FORMANS, TREVOUX Auvergne-Rhone-Alpes 01600 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCJLaparoscope, General & Plastic Surgery
- FTMMesh, Surgical
- OWTMesh, Surgical, Absorbable, Abdominal Hernia
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects
- OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
- FTLMesh, Surgical, Polymeric
- OTPMesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
- OTNMesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
- OODSurgical Film
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1523-2018 | 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 fascial deficiencies that require the addition of a reinforcing material. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain