510(k) K233661
K233661 is an FDA 510(k) premarket notification submitted by Sofradim Production for the device "Transorb Self-Gripping Resorbable Mesh". The FDA issued a decision of Substantially Equivalent on February 13, 2024. The device falls under product code OWT (Mesh, Surgical, Absorbable, Abdominal Hernia), a Class II device regulated under 21 CFR 878.3300. Sofradim Production has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2024
- Date Received
- November 15, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Absorbable, Abdominal Hernia
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
For reinforcement of soft tissue where weakness exists during hernia repair.