Product code LCJ
- Device name
- Tissue Expander And Accessories
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K254126 | Natrelle 133S Tissue Expanders | AbbVie | 2026-01-16 |
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | Mentor Worldwide, LLC | 2025-04-24 |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2025-01-12 |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | Mentor Worldwide, LLC | 2024-08-02 |
| K211676 | Motiva Flora SmoothSilk Tissue Expander | Motiva USA, LLC | 2023-10-13 |
| K214124 | AlloX2 Pro Tissue Expanders | Sientra, Inc. | 2023-06-08 |
| K221127 | Sientra, inc. Portfinder | Sientra, Inc. | 2023-05-10 |
| K180826 | Natrelle 133 Plus MICROCELL Tissue Expander | Allergan | 2018-12-21 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Mentor Worldwide, LLC | 2018-09-25 |
| K182054 | Natrelle 133S Tissue Expander | Allergan | 2018-08-29 |
| K161483 | Unger Quad Injector | Stradis Healthcare | 2016-10-31 |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | Mentor Worldwide, LLC | 2016-05-23 |
| K152496 | CPX 4 Breast Tissue Expander | Mentor Worldwide, LLC | 2016-02-19 |
| K143354 | Natrelle 133 Plus Tissue Expander | Allergan, Inc. | 2015-08-20 |
| K150777 | Artoura Breast Tissue Expander | Mentor Worldwide, LLC | 2015-04-24 |
| K142998 | CPX Control Breast Tissue Expander | Mentor Worldwide, LLC | 2014-12-19 |
| K140383 | ALLOX2 TISSUE EXPANDERS | Specialty Surgical Products, Inc. | 2014-10-28 |
| K131692 | BLOSSOM SALINE DELIVERY ASSIST DEVICE | Marz Medical, Inc. | 2014-07-10 |
| K130813 | MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS | Mentor Corp. | 2013-04-11 |
| K112534 | LIFECELL TISSUE EXPANDER | Lifecell Corp. | 2012-08-10 |
| K102806 | NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS | Allergan Medical | 2011-01-05 |
| K070303 | SILICONE TISSUE EXPANDER | Specialty Surgical Products | 2007-06-22 |
| K011500 | MENTOR CONTOUR PROFILE TISSUE EXPANDER | Mentor Corp. | 2001-12-03 |
| K983385 | HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS | Hutchison Intl., Inc. | 1999-03-15 |
| K983792 | SEARE BIOMEDICAL SILICONE TISSUE EXPANDER | Seare Biomedical Corp. | 1998-12-11 |
| K981852 | SILIMED TISSUE EXPANDER | Silimed, LLC | 1998-08-05 |
| K982067 | MAGNETIC PORT SILICONE TISSUE EXPANDER | Specialty Surgical Products, Inc. | 1998-07-13 |
| K974209 | SILICONE TISSUE/INFLATABLE TISSUE EXPANDER | Specialty Surgical Products, Inc. | 1998-02-06 |
| K963066 | MENTOR INJECTION PORT DETECTOR (IPD) | Mentor Corp. | 1996-09-27 |
| K905484 | ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT | Mentor Corp. | 1991-02-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00650551006596 | INTEGRA | PMT CORPORATION | 2026-05-27 |
| 00650551006022 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006039 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006046 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006060 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006077 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006084 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006176 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006237 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006503 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00650551006510 | INTEGRA | PMT CORPORATION | 2026-05-18 |
| 00840124521889 | PolyLock Midfoot | FUSION ORTHOPEDICS, LLC | 2025-10-02 |
| 10081317032332 | MENTOR CPX4 PLUS Enhance, Smooth, Tall Height | MENTOR TEXAS L.P. | 2025-03-26 |
| 00650551005391 | INTEGRA® | PMT CORPORATION | 2025-03-26 |
| 00650551002833 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551002963 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551002772 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551002161 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551003083 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551003090 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551002154 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551003168 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551003175 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 00650551003182 | INTEGRA® | PMT CORPORATION | 2025-03-19 |
| 04046955696277 | B.BRAUN | B. BRAUN MEDICAL INC. | 2021-05-15 |
| 04046964823749 | B.BRAUN | B. BRAUN MEDICAL INC. | 2017-07-24 |
| 04046964787102 | B.BRAUN | B. BRAUN MEDICAL INC. | 2015-10-11 |
| 04046964787119 | B.BRAUN | B. BRAUN MEDICAL INC. | 2015-10-11 |
| M746PPL010 | Precision Point Locator | SPECIALTY SURGICAL PRODUCTS INC | 2015-09-15 |
| M746AMSL010 | AlloX2 Magnetic Site Locator | SPECIALTY SURGICAL PRODUCTS INC | 2015-09-15 |