510(k) K211676
K211676 is an FDA 510(k) premarket notification submitted by Motiva USA, LLC for the device "Motiva Flora SmoothSilk Tissue Expander". The FDA issued a decision of Substantially Equivalent on October 13, 2023. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Motiva USA, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2023
- Date Received
- June 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Expander And Accessories
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type