LCJ — Tissue Expander And Accessories Class U
FDA Device Classification
Classification Details
- Product Code
- LCJ
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K254126 | abbvie | Natrelle 133S Tissue Expanders | January 16, 2026 |
| K242963 | mentor worldwide | MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | April 24, 2025 |
| K243836 | mentor worldwide | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | January 12, 2025 |
| K241918 | mentor worldwide | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | August 2, 2024 |
| K211676 | motiva usa | Motiva Flora SmoothSilk Tissue Expander | October 13, 2023 |
| K214124 | sientra | AlloX2 Pro Tissue Expanders | June 8, 2023 |
| K221127 | sientra | Sientra, inc. Portfinder | May 10, 2023 |
| K180826 | allergan | Natrelle 133 Plus MICROCELL Tissue Expander | December 21, 2018 |
| K182335 | mentor worldwide | CPX 4 Breast Tissue Expander with Smooth Surface | September 25, 2018 |
| K182054 | allergan | Natrelle 133S Tissue Expander | August 29, 2018 |
| K161483 | stradis healthcare | Unger Quad Injector | October 31, 2016 |
| K161176 | mentor worldwide | ARTOURA Breast Tissue Expanders with Smooth Surface | May 23, 2016 |
| K152496 | mentor worldwide | CPX 4 Breast Tissue Expander | February 19, 2016 |
| K143354 | allergan | Natrelle 133 Plus Tissue Expander | August 20, 2015 |
| K150777 | mentor worldwide | Artoura Breast Tissue Expander | April 24, 2015 |
| K142998 | mentor worldwide | CPX Control Breast Tissue Expander | December 19, 2014 |
| K140383 | specialty surgical products | ALLOX2 TISSUE EXPANDERS | October 28, 2014 |
| K131692 | marz medical | BLOSSOM SALINE DELIVERY ASSIST DEVICE | July 10, 2014 |
| K130813 | mentor | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TI | April 11, 2013 |
| K112534 | lifecell | LIFECELL TISSUE EXPANDER | August 10, 2012 |