LCJ

FDA Product Code LCJ: Tissue Expander And Accessories

Leading manufacturers include Mentor Corp., Mentor Worldwide, LLC and Surgitek.

55
Total
55
Cleared
142d
Avg days
1977
Since
Declining activity - 3 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 90d recently vs 145d historically

FDA 510(k) Cleared Tissue Expander And Accessories Devices (Product Code LCJ)

55 devices
1–24 of 55
Cleared Jan 16, 2026
Natrelle 133S Tissue Expanders
K254126
AbbVie
General & Plastic Surgery · 28d
Cleared Apr 24, 2025
MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs
K242963
Mentor Worldwide, LLC
General & Plastic Surgery · 211d
Cleared Jan 12, 2025
Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander
K243836
Mentor Worldwide, LLC
General & Plastic Surgery · 30d
Cleared Aug 02, 2024
MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander
K241918
Mentor Worldwide, LLC
General & Plastic Surgery · 32d
Cleared Oct 13, 2023
Motiva Flora SmoothSilk Tissue Expander
K211676
Motiva USA, LLC
General & Plastic Surgery · 864d
Cleared Jun 08, 2023
AlloX2 Pro Tissue Expanders
K214124
Sientra, Inc.
General & Plastic Surgery · 525d
Cleared May 10, 2023
Sientra, inc. Portfinder
K221127
Sientra, Inc.
General & Plastic Surgery · 387d
Cleared Dec 21, 2018
Natrelle 133 Plus MICROCELL Tissue Expander
K180826
Allergan
General & Plastic Surgery · 266d
Cleared Sep 25, 2018
CPX 4 Breast Tissue Expander with Smooth Surface
K182335
Mentor Worldwide, LLC
General & Plastic Surgery · 28d
Cleared Aug 29, 2018
Natrelle 133S Tissue Expander
K182054
Allergan
General & Plastic Surgery · 29d
Cleared Aug 20, 2015
Natrelle 133 Plus Tissue Expander
K143354
Allergan, Inc.
General & Plastic Surgery · 269d
Cleared Apr 11, 2013
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
K130813
Mentor Corp.
General & Plastic Surgery · 17d
Cleared Dec 03, 2001
MENTOR CONTOUR PROFILE TISSUE EXPANDER
K011500
Mentor Corp.
General & Plastic Surgery · 201d
Cleared Sep 27, 1996
MENTOR INJECTION PORT DETECTOR (IPD)
K963066
Mentor Corp.
General & Plastic Surgery · 51d
Cleared Feb 11, 1991
ACCU-TEC SYSTEM FOR TISSUE EXPANDER INJECTION PORT
K905484
Mentor Corp.
General & Plastic Surgery · 67d
Cleared Jan 14, 1991
SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDER
K903448
Medical Engineering Corp.
General & Plastic Surgery · 167d
Cleared Nov 26, 1990
MENTOR TISSUE EXPANDERS W/TDMAC COATING
K894475
Mentor Corp.
General & Plastic Surgery · 496d
Cleared Jan 17, 1990
SURGITEK(R) EXTERNAL FILL PORT
K894495
Surgitek
General & Plastic Surgery · 182d
Cleared Aug 10, 1989
SURGITEK FLAT T-SPAN
K884746
Medical Engineering Corp.
General & Plastic Surgery · 269d
Cleared Jun 12, 1989
RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)
K884250
Mentor Corp.
General & Plastic Surgery · 244d
Cleared Jun 10, 1986
MENTOR FLAT-SPAN
K862049
Mentor Corp.
General & Plastic Surgery · 12d
Cleared May 10, 1985
MENTOR EXPANDER MAMMARY PROSTHESIS
K844813
Mentor Corp.
General & Plastic Surgery · 150d
Cleared Aug 17, 1984
RADOVAN TISSUE EXPANDER
K842883
Mentor Corp.
General & Plastic Surgery · 25d
Cleared Mar 12, 1984
TISSUE EXPANDER
K840464
Surgitek
General & Plastic Surgery · 38d

About Product Code LCJ - Regulatory Context

510(k) Submission Activity

55 total 510(k) submissions under product code LCJ since 1977, with 55 receiving FDA clearance (average review time: 142 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 4 in the prior period.

FDA 510(k) Review Time - LCJ Product Code

Recent submissions under LCJ have taken an average of 90 days to reach a decision - down from 145 days historically, suggesting improved FDA processing for this classification.

LCJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →