PARIEFIX— 510(k) K032093
Substantially EquivalentSofradim Production
FDA 510(k) clearance K032093 for PARIEFIX, Substantially Equivalent on 2003-10-22. Applicant: Sofradim Production. Device class: 2.
Clearance details
- Applicant
- Sofradim Production
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ayer, MA, US
Recent devices under product code GCJ
view allMore clearances from Sofradim Production
view all- K262443 — Transorb Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
- K253956 — ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)
- K250869 — Parietene Macroporous Mesh (PPM5050 )
- K243315 — ProGrip Self-Gripping Polypropylene Mesh
- K233661 — Transorb Self-Gripping Resorbable Mesh
Adverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.