510(k) K214070
K214070 is an FDA 510(k) premarket notification submitted by Tela Bio for the device "OviTex PRS (Long Term Resorbable)". The FDA issued a decision of Substantially Equivalent on March 21, 2023. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Tela Bio has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 21, 2023
- Date Received
- December 27, 2021
- Clearance Type
- Traditional
- 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