LCJ · Tissue Expander And Accessories
· Class U
Overview
| Product Code | LCJ |
|---|---|
| Device Name | Tissue Expander And Accessories |
| Device Class | Class U |
| Review Panel | |
| Implant | Yes |
Recent Cleared Devices (20 of 55)
Showing 20 most recent of 55 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | Jan 16, 2026 | SESE |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | Apr 24, 2025 | SESE |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | Jan 12, 2025 | SESE |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | Aug 2, 2024 | SESE |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | Oct 13, 2023 | SESE |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | Jun 8, 2023 | SESE |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | May 10, 2023 | SESE |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | Dec 21, 2018 | SESE |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | Sep 25, 2018 | SESE |
| K182054 | Natrelle 133S Tissue Expander | Allergan | Aug 29, 2018 | SESE |
| K161483 | Unger Quad Injector | Stradis Healthcare | Oct 31, 2016 | SESE |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | May 23, 2016 | SESE |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | Feb 19, 2016 | SESE |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | Aug 20, 2015 | SESE |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | Apr 24, 2015 | SESE |
| K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | Dec 19, 2014 | SESE |
| K140383 | ALLOX2 TISSUE EXPANDERS | Specialty Surgical Products, Inc. | Oct 28, 2014 | SESE |
| K131692 | BLOSSOM SALINE DELIVERY ASSIST DEVICE | Marz Medical, Inc. | Jul 10, 2014 | SESE |
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | Mentor Corp. | Apr 11, 2013 | SESE |
| K112534 | LIFECELL TISSUE EXPANDER | Lifecell Corp. | Aug 10, 2012 | SESE |
Top Applicants
- Mentor Corp. — 9 clearances
- Mentor Worldwide, LLC — 8 clearances
- Mcghan Medical Corp. — 7 clearances
- Specialty Surgical Products, Inc. — 3 clearances
- Allergan — 2 clearances