510(k) clearance
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
- 510(k) number
- K262443
- Applicant
- Sofradim Production
- Decision date
- Oct 16, 2026
- Date received
- Jul 16, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- OWT
- Device type
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Trévoux, FR