510(k) clearance
Liora Monofilament Scaffold
- 510(k) number
- K260474
- Applicant
- TELA Bio, Inc.
- Decision date
- Sep 28, 2026
- Date received
- Feb 12, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- FTL
- Device type
- Mesh, Surgical, Polymeric
- Device class
- Class II
- Regulation
- 21 CFR 878.3300
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Malvern, PA, US