510(k) K260474
K260474 is an FDA 510(k) premarket notification submitted by TELA Bio, Inc. for the device "Liora Monofilament Scaffold". The FDA issued a decision of Substantially Equivalent on Sep 28, 2026. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300. TELA Bio, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 28, 2026
- Date Received
- Feb 12, 2026
- Clearance Type
- Traditional
- 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
- 510(k)