Company · US
Sofradim Production
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 37 |
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 2 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 2 |
| OWT | Mesh, Surgical, Absorbable, Abdominal Hernia | 2 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 16, 2026 | K262443 | Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030) Sofradim Production, FR | OWT |
| May 21, 2026 | K253956 | ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) Sofradim Production, FR | FTL |
| Apr 23, 2025 | K250869 | Parietene Macroporous Mesh (PPM5050 ) Sofradim Production, FR | FTL |
| Jan 17, 2025 | K243315 | ProGrip Self-Gripping Polypropylene Mesh Sofradim Production, FR | FTL |
| Feb 13, 2024 | K233661 | Transorb Self-Gripping Resorbable Mesh Sofradim Production, FR | OWT |
| Jan 18, 2024 | K232373 | Progrip Self-Gripping Polypropylene Mesh Sofradim Production, FR | FTL |
| Dec 2, 2022 | K223218 | Parietene Macroporous Mesh Sofradim Production, FR | FTL |
| Jun 22, 2022 | K220586 | Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Mono Sofradim Production, FR | FTL |
| Dec 6, 2019 | K192443 | Dextile Anatomical Mesh Sofradim Production, FR | FTL |
| Mar 9, 2018 | K173796 | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PC Sofradim Production, FR | FTL |
| Feb 1, 2018 | K172395 | Duatene bilayer mesh Sofradim Production, FR | FTL |
| Jun 29, 2017 | K163212 | Parietene DS Composite Mesh Sofradim Production, FR | FTL |
| May 26, 2015 | K150091 | Versatex Monofilament Mesh Sofradim Production, FR | FTL |
| Mar 13, 2015 | K143386 | Progrip Laparoscopic Self-Fixating Mesh Sofradim Production, FR | FTL |
| Nov 14, 2014 | K142908 | Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: P Sofradim Production, FR | FTL |
| Oct 28, 2014 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plu Sofradim Production, FR | FTL |
| Oct 17, 2014 | K142091 | PARIETENE MACROPOROUS MESH Sofradim Production | FTL |
| May 7, 2014 | K140941 | PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH Sofradim Production | FTL |
| Aug 22, 2013 | K131969 | SYMBOTEX(TM) COMPOSITE MESH Sofradim Production | FTL |
| Dec 11, 2012 | K123479 | PROGRIP LAPAROSCOPIC SELF-FIXATING MESH Sofradim Production | FTL |
| Jun 29, 2012 | K120897 | PROGRIP LAPARSCOPIC SELF-FIXATING MESH Sofradim Production | FTL |
| Jun 13, 2012 | K120506 | PARIETEX COMPOSITE VENTRAL PATCH Sofradim Production | FTL |
| Aug 11, 2011 | K110663 | PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES) Sofradim Production | FTL |
| Apr 19, 2011 | K110816 | PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES) Sofradim Production | FTL |
| Apr 19, 2011 | K110815 | PARIETEX OPTIMIZED COMPOSTIE MESH Sofradim Production | FTL |
| Mar 4, 2011 | K103682 | PARIETEX PROGRIP Sofradim Production | FTL |
| Nov 5, 2010 | K101519 | PARIETEX PLUG AND PATCH Sofradim Production | FTL |
| May 5, 2010 | K101197 | PARIE TENE PROGRIP MESH Sofradim Production | FTL |
| May 6, 2009 | K090858 | PARIETEX MONOFILAMENT POLYESTER MESH Sofradim Production | FTL |
| Aug 13, 2008 | K081126 | PARIETEX COMPOSITE MONO PM MESH Sofradim Production | FTL |
| May 28, 2008 | K081050 | PARIETEX PROGRIP MESH Sofradim Production | FTL |
| Mar 13, 2008 | K073287 | PREVADH MESH Sofradim Production | FTL |
| Dec 19, 2007 | K072951 | PARIETENE DUO AND QUADRA POLYPROPYLENE MESHES Sofradim Production | OTP |
| Jul 10, 2007 | K071629 | PARIETEX POLYESTER MESH WITH INTRODUCER Sofradim Production | FTL |
| Aug 5, 2005 | K051503 | UGYTEX SUAL KNIT MESH Sofradim Production | OTP |
| Feb 18, 2005 | K050187 | PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES Sofradim Production | FTL |
| May 17, 2004 | K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM Sofradim Production | OTN |
| Apr 29, 2004 | K040998 | MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH Sofradim Production | FTL |
| Jan 15, 2004 | K033376 | UGYTEX MESH Sofradim Production | FTL |
| Oct 22, 2003 | K032093 | PARIEFIX Sofradim Production | GCJ |
| Oct 4, 2001 | K012949 | URETEX SUP PUBOURETHRAL SLING Sofradim Production | OTN |
| Jan 24, 2001 | K003990 | SOFRADIM PARIETEX SURGICAL MESHES Sofradim Production | FTL |
| Jul 12, 1999 | K991400 | PARIETENE POLYPROPYLENE MESH Sofradim Production | FTL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2018 | Sofradim Production 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 wa Terminated |
FTL | K150091 |