510(k) K213125
K213125 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies. Inc. (A Subsidiary of Baxter for the device "PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology". The FDA issued a decision of Substantially Equivalent on October 27, 2021. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 27, 2021
- Date Received
- September 27, 2021
- 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