510(k) K221127
K221127 is an FDA 510(k) premarket notification submitted by Sientra, Inc. for the device "Sientra, inc. Portfinder". The FDA issued a decision of Substantially Equivalent on May 10, 2023. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. Sientra, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2023
- Date Received
- April 18, 2022
- 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