510(k) K254126
K254126 is an FDA 510(k) premarket notification submitted by AbbVie for the device "Natrelle 133S Tissue Expanders". The FDA issued a decision of Substantially Equivalent on January 16, 2026. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device. AbbVie has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 16, 2026
- Date Received
- December 19, 2025
- Clearance Type
- Special
- 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