510(k) K253125
K253125 is an FDA 510(k) premarket notification submitted by Medtronic - Sofradim Production for the device "Parietene Flat Sheet Mesh". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2025
- Date Received
- September 25, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Polymeric
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type