Product Code: LCJ FDA unclassified

Tissue Expander And Accessories

Unknown

Tissue expanders and accessories are implantable medical devices used in plastic and reconstructive surgery to gradually stretch skin and soft tissue before final implant placement, such as in breast reconstruction following mastectomy. This device type is currently unclassified by the FDA, meaning formal classification has not been finalized and its regulatory pathway remains under review. The product code is LCJ, with no regulation number or medical specialty assigned. This device is flagged as an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LCJ
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✓

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K254126	Natrelle 133S Tissue Expanders	Jan 16, 2026	Substantially Equivalent	AbbVie
K242963	MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs	Apr 24, 2025	Substantially Equivalent	Mentor Worldwide, LLC
K243836	Mentor CPX 4 PLUS Enhance Breast Tissue Expander	Jan 12, 2025	Substantially Equivalent	Mentor Worldwide, LLC
K241918	MENTOR CPX4 PLUS Enhance Breast Tissue Expander	Aug 02, 2024	Substantially Equivalent	Mentor Worldwide, LLC
K211676	Motiva Flora SmoothSilk Tissue Expander	Oct 13, 2023	Substantially Equivalent	Motiva USA, LLC
K214124	AlloX2 Pro Tissue Expanders	Jun 08, 2023	Substantially Equivalent	Sientra, Inc.
K221127	Sientra, inc. Portfinder	May 10, 2023	Substantially Equivalent	Sientra, Inc.
K180826	Natrelle 133 Plus MICROCELL Tissue Expander	Dec 21, 2018	Substantially Equivalent	Allergan
K182335	CPX 4 Breast Tissue Expander with Smooth Surface	Sep 25, 2018	Substantially Equivalent	Mentor Worldwide, LLC
K182054	Natrelle 133S Tissue Expander	Aug 29, 2018	Substantially Equivalent	Allergan
K161483	Unger Quad Injector	Oct 31, 2016	Substantially Equivalent	Stradis Healthcare
K161176	ARTOURA Breast Tissue Expanders with Smooth Surface	May 23, 2016	Substantially Equivalent	Mentor Worldwide, LLC
K152496	CPX 4 Breast Tissue Expander	Feb 19, 2016	Substantially Equivalent	Mentor Worldwide, LLC
K143354	Natrelle 133 Plus Tissue Expander	Aug 20, 2015	Substantially Equivalent	Allergan, Inc.
K150777	Artoura Breast Tissue Expander	Apr 24, 2015	Substantially Equivalent	Mentor Worldwide, LLC
K142998	CPX Control Breast Tissue Expander	Dec 19, 2014	Substantially Equivalent	Mentor Worldwide, LLC
K140383	ALLOX2 TISSUE EXPANDERS	Oct 28, 2014	Substantially Equivalent	Specialty Surgical Products, Inc.
K131692	BLOSSOM SALINE DELIVERY ASSIST DEVICE	Jul 10, 2014	Substantially Equivalent	Marz Medical, Inc.
K130813	MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS	Apr 11, 2013	Substantially Equivalent	Mentor Corp.
K112534	LIFECELL TISSUE EXPANDER	Aug 10, 2012	Substantially Equivalent	Lifecell Corp.
K102806	NATRELLE 133 TISSUE EXPANDER WITH SUTURE TABS	Jan 05, 2011	Substantially Equivalent	Allergan Medical
K070303	SILICONE TISSUE EXPANDER	Jun 22, 2007	Substantially Equivalent	Specialty Surgical Products
K011500	MENTOR CONTOUR PROFILE TISSUE EXPANDER	Dec 03, 2001	Substantially Equivalent	Mentor Corp.
K983385	HUTCHISON INFLATABLE SILICONE TISSUE EXPANDERS	Mar 15, 1999	Substantially Equivalent	Hutchison Intl., Inc.
K983792	SEARE BIOMEDICAL SILICONE TISSUE EXPANDER	Dec 11, 1998	Substantially Equivalent	Seare Biomedical Corp.
K981852	SILIMED TISSUE EXPANDER	Aug 05, 1998	Substantially Equivalent	Silimed, LLC
K982067	MAGNETIC PORT SILICONE TISSUE EXPANDER	Jul 13, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K974209	SILICONE TISSUE/INFLATABLE TISSUE EXPANDER	Feb 06, 1998	Substantially Equivalent	Specialty Surgical Products, Inc.
K963066	MENTOR INJECTION PORT DETECTOR (IPD)	Sep 27, 1996	Substantially Equivalent	Mentor Corp.
K905484	ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT	Feb 11, 1991	Substantially Equivalent	Mentor Corp.
K903448	SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER	Jan 14, 1991	Substantially Equivalent	Medical Engineering Corp.
K894475	MENTOR TISSUE EXPANDERS W/TDMAC COATING	Nov 26, 1990	Substantially Equivalent	Mentor Corp.
K894495	SURGITEK(R) EXTERNAL FILL PORT	Jan 17, 1990	Substantially Equivalent	Surgitek
K884746	SURGITEK FLAT T-SPAN	Aug 10, 1989	Substantially Equivalent	Medical Engineering Corp.
K884250	RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)	Jun 12, 1989	Substantially Equivalent	Mentor Corp.
K865056	CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER	May 22, 1987	Substantially Equivalent	Cox-Uphuff Intl.
K870754	MCGHAN TISSUE EXPANDER FILL SYSTEM	Mar 31, 1987	Substantially Equivalent	Mcghan Medical Corp.
K870154	POREX(TM) TISSUE EXPANDER	Feb 24, 1987	Substantially Equivalent	Porex Medical
K865033	BREAST PROSTHESIS (NON & INFLATABLE) SKIN EXPANDER	Jan 12, 1987	Substantially Equivalent	Cox-Uphuff Intl.
K864185	MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN	Dec 24, 1986	Substantially Equivalent	Mcghan Medical Corp.
K864184	MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN	Dec 24, 1986	Substantially Equivalent	Mcghan Medical Corp.
K862203	MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER	Jul 23, 1986	Substantially Equivalent	Mcghan Medical Corp.
K862049	MENTOR FLAT-SPAN	Jun 10, 1986	Substantially Equivalent	Mentor Corp.
K854794	MCGHAN INTEGRAL VALVE TISSUE EXPANDER	Dec 24, 1985	Substantially Equivalent	Mcghan Medical Corp.
K853014	MCGHAN TISSUE EXPANDER FILL KIT	Sep 18, 1985	Substantially Equivalent	Mcghan Medical Corp.
K845036	TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600	Jun 26, 1985	Substantially Equivalent	Progress Mankind Technology
K844813	MENTOR EXPANDER MAMMARY PROSTHESIS	May 10, 1985	Substantially Equivalent	Mentor Corp.
K843678	CREAT BRAND SKIN EXPANDER	Nov 06, 1984	Substantially Equivalent	Aesthetech Corp.
K843704	MCGHAN TISSUE EXPANDER	Oct 31, 1984	Substantially Equivalent	Mcghan Medical Corp.
K842883	RADOVAN TISSUE EXPANDER	Aug 17, 1984	Substantially Equivalent	Mentor Corp.
K840464	TISSUE EXPANDER	Mar 12, 1984	Substantially Equivalent	Surgitek
K833502	RADOVAN SUBCUTANEOUS TISSUE EXPANDER	Feb 03, 1984	Substantially Equivalent	American Heyer Schulte
K801042	SILASTIC BRAND PERCUTANEOUS SKIN EXPANDE	Jun 26, 1980	Substantially Equivalent	Dow Corning Corp. Healthcare Industries Materials
K790842	SUBCUTANEOUS TISSUE EXPANDER	Aug 03, 1979	Substantially Equivalent	Heyer Schulte Corp.
K771224	RADOVAN SUBCUTANEOUS TISSUE EXPANDER	Oct 11, 1977	Substantially Equivalent	Heyer Schulte Corp.