ClearanceBrief
Product code LCJ ยท Class U

Tissue Expander And Accessories

1510(k)s in 12 months (55 all time)
10recalls in 12 months (21 all time)
18recalls that name a 510(k)
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Top companies in LCJ

DateFirm and productCodeLinked 510(k)
Mar 27, 2026Mentor Texas, LP.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Open, Classified
LCJK161176
Mar 27, 2026Mentor Texas, LP.
Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc
Open, Classified
LCJK161176
Mar 27, 2026Mentor Texas, LP.
Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 53
Open, Classified
LCJK150777
Mar 27, 2026Mentor Texas, LP.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc
Open, Classified
LCJK241918
Mar 27, 2026Mentor Texas, LP.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH, SCPX-117MH,SCPX-127MH, SCPX-135MH, SCPX-146MH, SCPX-156MH Smooth Medium Height Tissue Expander, 275cc, 350cc, 450cc, 5
Open, Classified
LCJK241918
Mar 27, 2026Mentor Texas, LP.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
Open, Classified
LCJK241918
Mar 27, 2026Mentor Texas, LP.
CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)
Open, Classified
LCJK130813
Mar 2, 2026B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used t
Open, Classified
LCJNone listed
Mar 2, 2026B Braun Medical Inc
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended
Open, Classified
LCJNone listed
Mar 2, 2026B Braun Medical Inc
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and inte
Open, Classified
LCJNone listed
Nov 3, 2023B. Braun Medical, Inc.
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Open, Classified
LCJK853014
Sep 11, 2019Allergan PLC
McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection unti
Open, Classified
LCJK862203
Sep 11, 2019Allergan PLC
Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133
Open, Classified
LCJK102806
K862203
Sep 11, 2019Allergan PLC
Natrelle133 Plus Tissue Expander With/Without Suture Tabs, BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion Set, Sterile, for the following style numbers: STYLE 133
Open, Classified
LCJK143354
Sep 11, 2019Allergan PLC
Natrelle 133 Tissue Expanders (also named style 133 BIOSPAN Tissue Expander and Mcghan Magna-Site Tissue Expander) BioCell Full Height Variable Projection with Magna-Fider Xact & 21G Needle Infusion S
Open, Classified
LCJK102806
K862203
Sep 10, 2016Mentor Texas, LP.
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect pr
Terminated
LCJK130813
Sep 10, 2016Mentor Texas, LP.
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect p
Terminated
LCJK150777
Sep 7, 2016Mentor Texas, LP.
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for
Terminated
LCJK130813
Sep 7, 2016Mentor Texas, LP.
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for
Terminated
LCJK130813
Jul 18, 2015Allergan Inc
Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive cor
Terminated
LCJK865056
Jul 18, 2015Allergan Inc
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile sa
Terminated
LCJK862203

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