URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM— 510(k) K041176
Substantially EquivalentSofradim Production
FDA 510(k) clearance K041176 for URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM, Substantially Equivalent on 2004-05-17. Applicant: Sofradim Production. Device class: 2.
Clearance details
- Applicant
- Sofradim Production
- Product code
- Product code OTN
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Ayer, MA, US
Recent devices under product code OTN
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 OTN
product code OTN- Injury
- 6,630
- Total
- 6,630
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.