LCJ
- Product code
- LCJ
- Device name
- Tissue Expander And Accessories
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 55 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254126 | 2026-01-16 | AbbVie | Natrelle 133S Tissue Expanders | |
| K242963 | 2025-04-24 | Mentor Worldwide, LLC | MENTOR PliaForm Breast Tissue Expander w/ Suture T… | |
| K243836 | 2025-01-12 | Mentor Worldwide, LLC | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | |
| K241918 | 2024-08-02 | Mentor Worldwide, LLC | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | |
| K211676 | 2023-10-13 | Motiva USA, LLC | Motiva Flora SmoothSilk Tissue Expander |
Official FDA classification page: LCJ
Classification and pathway per current FDA publications. Data from openFDA (CC0).