Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Tissue Expander And Accessories

FDA product code LCJ · 50 cleared devices

Class U Unknown

Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-10-11 – 2026-01-16

LCJ 2026-01-16

Natrelle 133S Tissue Expanders

Applicant AbbVie

K number K254126

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LCJ 2025-04-24

MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs

Applicant Mentor Worldwide, LLC

K number K242963

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LCJ 2025-01-12

Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander

Applicant Mentor Worldwide, LLC

K number K243836

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LCJ 2024-08-02

MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander

Applicant Mentor Worldwide, LLC

K number K241918

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LCJ 2023-10-13

Motiva Flora SmoothSilk Tissue Expander

Applicant Motiva USA, LLC

K number K211676

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LCJ 2023-06-08

AlloX2 Pro Tissue Expanders

Applicant Sientra, Inc.

K number K214124

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LCJ 2023-05-10

Sientra, inc. Portfinder

Applicant Sientra, Inc.

K number K221127

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LCJ 2018-12-21

Natrelle 133 Plus MICROCELL Tissue Expander

Applicant Allergan

K number K180826

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LCJ 2018-09-25

CPX 4 Breast Tissue Expander with Smooth Surface

Applicant Mentor Worldwide, LLC

K number K182335

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LCJ 2018-08-29

Natrelle 133S Tissue Expander

Applicant Allergan

K number K182054

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LCJ 2016-10-31

Unger Quad Injector

Applicant Stradis Healthcare

K number K161483

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LCJ 2016-05-23

ARTOURA Breast Tissue Expanders with Smooth Surface

Applicant Mentor Worldwide, LLC

K number K161176

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LCJ 2016-02-19

CPX 4 Breast Tissue Expander

Applicant Mentor Worldwide, LLC

K number K152496

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LCJ 2013-04-11

MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS

Applicant Mentor Corp.

K number K130813

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LCJ 2012-08-10

LIFECELL TISSUE EXPANDER

Applicant Lifecell Corp.

K number K112534

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LCJ 2011-01-05

NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS

Applicant Allergan Medical

K number K102806

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LCJ 2007-06-22

SILICONE TISSUE EXPANDER

Applicant Specialty Surgical Products

K number K070303

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LCJ 2001-12-03

MENTOR CONTOUR PROFILE TISSUE EXPANDER

Applicant Mentor Corp.

K number K011500

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LCJ 1999-03-15

HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS

Applicant Hutchison Intl., Inc.

K number K983385

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LCJ 1998-12-11

SEARE BIOMEDICAL SILICONE TISSUE EXPANDER

Applicant Seare Biomedical Corp.

K number K983792

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LCJ 1998-08-05

SILIMED TISSUE EXPANDER

Applicant Silimed, LLC

K number K981852

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LCJ 1998-07-13

MAGNETIC PORT SILICONE TISSUE EXPANDER

Applicant Specialty Surgical Products, Inc.

K number K982067

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LCJ 1998-02-06

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER

Applicant Specialty Surgical Products, Inc.

K number K974209

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LCJ 1996-09-27

MENTOR INJECTION PORT DETECTOR (IPD)

Applicant Mentor Corp.

K number K963066

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LCJ 1991-02-11

ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT

Applicant Mentor Corp.

K number K905484

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LCJ 1991-01-14

SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER

Applicant Medical Engineering Corp.

K number K903448

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LCJ 1990-11-26

MENTOR TISSUE EXPANDERS W/TDMAC COATING

Applicant Mentor Corp.

K number K894475

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LCJ 1990-01-17

SURGITEK(R) EXTERNAL FILL PORT

Applicant Surgitek

K number K894495

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LCJ 1989-08-10

SURGITEK FLAT T-SPAN

Applicant Medical Engineering Corp.

K number K884746

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LCJ 1989-06-12

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)

Applicant Mentor Corp.

K number K884250

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LCJ 1987-05-22

CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER

Applicant Cox-Uphuff Intl.

K number K865056

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LCJ 1987-03-31

MCGHAN TISSUE EXPANDER FILL SYSTEM

Applicant Mcghan Medical Corp.

K number K870754

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LCJ 1987-02-24

POREX(TM) TISSUE EXPANDER

Applicant Porex Medical

K number K870154

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LCJ 1987-01-12

BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER

Applicant Cox-Uphuff Intl.

K number K865033

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LCJ 1986-12-24

MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN

Applicant Mcghan Medical Corp.

K number K864185

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LCJ 1986-12-24

MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN

Applicant Mcghan Medical Corp.

K number K864184

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LCJ 1986-07-23

MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER

Applicant Mcghan Medical Corp.

K number K862203

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LCJ 1986-06-10

MENTOR FLAT-SPAN

Applicant Mentor Corp.

K number K862049

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LCJ 1985-12-24

MCGHAN INTEGRAL VALVE TISSUE EXPANDER

Applicant Mcghan Medical Corp.

K number K854794

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LCJ 1985-09-18

MCGHAN TISSUE EXPANDER FILL KIT

Applicant Mcghan Medical Corp.

K number K853014

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LCJ 1985-06-26

TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600

Applicant Progress Mankind Technology

K number K845036

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LCJ 1985-05-10

MENTOR EXPANDER MAMMARY PROSTHESIS

Applicant Mentor Corp.

K number K844813

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LCJ 1984-11-06

CREAT BRAND SKIN EXPANDER

Applicant Aesthetech Corp.

K number K843678

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LCJ 1984-10-31

MCGHAN TISSUE EXPANDER

Applicant Mcghan Medical Corp.

K number K843704

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LCJ 1984-08-17

RADOVAN TISSUE EXPANDER

Applicant Mentor Corp.

K number K842883

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LCJ 1984-03-12

TISSUE EXPANDER

Applicant Surgitek

K number K840464

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LCJ 1984-02-03

RADOVAN SUBCUTANEOUS TISSUE EXPANDER

Applicant American Heyer Schulte

K number K833502

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LCJ 1980-06-26

SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K801042

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LCJ 1979-08-03

SUBCUTANEOUS TISSUE EXPANDER

Applicant Heyer Schulte Corp.

K number K790842

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LCJ 1977-10-11

RADOVAN SUBCUTANEOUS TISSUE EXPANDER

Applicant Heyer Schulte Corp.

K number K771224

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