510(k) K211132
K211132 is an FDA 510(k) premarket notification submitted by Ariste Medical, LLC for the device "ARISTE AB Mesh". The FDA issued a decision of Substantially Equivalent on March 18, 2022. The device falls under product code FTL (Mesh, Surgical, Polymeric), a Class II device regulated under 21 CFR 878.3300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 2022
- Date Received
- April 16, 2021
- 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