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)
Top companies in LCJ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Mentor 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 |
LCJ | K161176 |
| Mar 27, 2026 | Mentor 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 |
LCJ | K161176 |
| Mar 27, 2026 | Mentor 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 |
LCJ | K150777 |
| Mar 27, 2026 | Mentor 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 |
LCJ | K241918 |
| Mar 27, 2026 | Mentor 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 |
LCJ | K241918 |
| Mar 27, 2026 | Mentor Texas, LP. CPX 4 US Breast Tissue Expanders with Suture Tabs
Reference Numbers: SCPX-157LH
Smooth Low Height Tissue Expander, 650cc Open, Classified |
LCJ | K241918 |
| Mar 27, 2026 | Mentor 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 |
LCJ | K130813 |
| Mar 2, 2026 | B 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 |
LCJ | None listed |
| Mar 2, 2026 | B 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 |
LCJ | None listed |
| Mar 2, 2026 | B 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 |
LCJ | None listed |
| Nov 3, 2023 | B. Braun Medical, Inc. ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Open, Classified |
LCJ | K853014 |
| Sep 11, 2019 | Allergan 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 |
LCJ | K862203 |
| Sep 11, 2019 | Allergan 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 |
LCJ | K102806 K862203 |
| Sep 11, 2019 | Allergan 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 |
LCJ | K143354 |
| Sep 11, 2019 | Allergan 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 |
LCJ | K102806 K862203 |
| Sep 10, 2016 | Mentor 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 |
LCJ | K130813 |
| Sep 10, 2016 | Mentor 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 |
LCJ | K150777 |
| Sep 7, 2016 | Mentor 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 |
LCJ | K130813 |
| Sep 7, 2016 | Mentor 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 |
LCJ | K130813 |
| Jul 18, 2015 | Allergan 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 |
LCJ | K865056 |
| Jul 18, 2015 | Allergan 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 |
LCJ | K862203 |
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