Atlas FDA

LCJ

55 FDA 510(k) clearances · Product code

71 daysmedian time to decision
344 days90th percentile
55clearances measured

FDA profile

Official device name
Tissue Expander And Accessories
Device class
Unclassified
Medical specialty
Unknown
Flags
Implant
Adverse events (MAUDE)
2021: 440 · 2022: 499 · 2023: 473 · 2024: 488 · 2025: 500 · 2026: 229
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Natrelle 133S Tissue Expanders (K254126)AbbVie2026-01-16
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs (K242963)Mentor Worldwide, LLC2025-04-24
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander (K243836)Mentor Worldwide, LLC2025-01-12
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander (K241918)Mentor Worldwide, LLC2024-08-02
Motiva Flora SmoothSilk Tissue Expander (K211676)Motiva USA, LLC2023-10-13
AlloX2 Pro Tissue Expanders (K214124)Sientra, Inc.2023-06-08
Sientra, inc. Portfinder (K221127)Sientra, Inc.2023-05-10
Natrelle 133 Plus MICROCELL Tissue Expander (K180826)Allergan2018-12-21
CPX 4 Breast Tissue Expander with Smooth Surface (K182335)Mentor Worldwide, LLC2018-09-25
Natrelle 133S Tissue Expander (K182054)Allergan2018-08-29
Unger Quad Injector (K161483)Stradis Healthcare2016-10-31
ARTOURA Breast Tissue Expanders with Smooth Surface (K161176)Mentor Worldwide, LLC2016-05-23
CPX 4 Breast Tissue Expander (K152496)Mentor Worldwide, LLC2016-02-19
Natrelle 133 Plus Tissue Expander (K143354)Allergan, Inc.2015-08-20
Artoura Breast Tissue Expander (K150777)Mentor Worldwide, LLC2015-04-24
CPX Control Breast Tissue Expander (K142998)Mentor Worldwide, LLC2014-12-19
ALLOX2 TISSUE EXPANDERS (K140383)Specialty Surgical Products, Inc.2014-10-28
BLOSSOM SALINE DELIVERY ASSIST DEVICE (K131692)Marz Medical, Inc.2014-07-10
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS (K130813)Mentor Corp.2013-04-11
LIFECELL TISSUE EXPANDER (K112534)Lifecell Corp.2012-08-10
NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS (K102806)Allergan Medical2011-01-05
SILICONE TISSUE EXPANDER (K070303)Specialty Surgical Products2007-06-22
MENTOR CONTOUR PROFILE TISSUE EXPANDER (K011500)Mentor Corp.2001-12-03
HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS (K983385)Hutchison Intl., Inc.1999-03-15
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER (K983792)Seare Biomedical Corp.1998-12-11
SILIMED TISSUE EXPANDER (K981852)Silimed, LLC1998-08-05
MAGNETIC PORT SILICONE TISSUE EXPANDER (K982067)Specialty Surgical Products, Inc.1998-07-13
SILICONE TISSUE/INFLATABLE TISSUE EXPANDER (K974209)Specialty Surgical Products, Inc.1998-02-06
MENTOR INJECTION PORT DETECTOR (IPD) (K963066)Mentor Corp.1996-09-27
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT (K905484)Mentor Corp.1991-02-11
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER (K903448)Medical Engineering Corp.1991-01-14
MENTOR TISSUE EXPANDERS W/TDMAC COATING (K894475)Mentor Corp.1990-11-26
SURGITEK(R) EXTERNAL FILL PORT (K894495)Surgitek1990-01-17
SURGITEK FLAT T-SPAN (K884746)Medical Engineering Corp.1989-08-10
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) (K884250)Mentor Corp.1989-06-12
CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER (K865056)Cox-Uphuff Intl.1987-05-22
MCGHAN TISSUE EXPANDER FILL SYSTEM (K870754)Mcghan Medical Corp.1987-03-31
POREX(TM) TISSUE EXPANDER (K870154)Porex Medical1987-02-24
BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER (K865033)Cox-Uphuff Intl.1987-01-12
MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN (K864184)Mcghan Medical Corp.1986-12-24
MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN (K864185)Mcghan Medical Corp.1986-12-24
MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER (K862203)Mcghan Medical Corp.1986-07-23
MENTOR FLAT-SPAN (K862049)Mentor Corp.1986-06-10
MCGHAN INTEGRAL VALVE TISSUE EXPANDER (K854794)Mcghan Medical Corp.1985-12-24
MCGHAN TISSUE EXPANDER FILL KIT (K853014)Mcghan Medical Corp.1985-09-18
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600 (K845036)Progress Mankind Technology1985-06-26
MENTOR EXPANDER MAMMARY PROSTHESIS (K844813)Mentor Corp.1985-05-10
CREAT BRAND SKIN EXPANDER (K843678)Aesthetech Corp.1984-11-06
MCGHAN TISSUE EXPANDER (K843704)Mcghan Medical Corp.1984-10-31
RADOVAN TISSUE EXPANDER (K842883)Mentor Corp.1984-08-17
TISSUE EXPANDER (K840464)Surgitek1984-03-12
RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K833502)American Heyer Schulte1984-02-03
SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE (K801042)Dow Corning Corp. Healthcare Industries Materials1980-06-26
SUBCUTANEOUS TISSUE EXPANDER (K790842)Heyer Schulte Corp.1979-08-03
RADOVAN SUBCUTANEOUS TISSUE EXPANDER (K771224)Heyer Schulte Corp.1977-10-11

Track LCJ automatically

Every clearance here is in the API, with alerts when new ones post.