510(k) K243595
K243595 is an FDA 510(k) premarket notification submitted by TELA Bio, Inc. for the device "OviTex PRS (Long-Term Resorbable)". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. TELA Bio, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2024
- Date Received
- November 20, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type