MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS— 510(k) K130813

Clearance details

Applicant

Mentor Corp.

Product code

Code LCJ

Device class

Unclassified

Advisory panel

Unknown

Date received

2013-03-25

Decision date

2013-04-11

Decision

Substantially Equivalent

Clearance type

Special

Location

Santa Barbara, CA, US

• K254126 — Natrelle 133S Tissue Expanders2026-01-16
• K242963 — MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs2025-04-24
• K243836 — Mentor CPX 4 PLUS Enhance Breast Tissue Expander2025-01-12
• K241918 — MENTOR CPX4 PLUS Enhance Breast Tissue Expander2024-08-02
• K211676 — Motiva Flora SmoothSilk Tissue Expander2023-10-13

• K053414 — MENTOR NOVASILK MESH2005-12-27
• K050008 — MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER2005-06-03
• K042851 — MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT2004-11-09
• K040959 — MENTOR GENESIS PENILE PROSTHESIS2004-10-29
• K031767 — MENTOR OBTAPE TRANS-OBTURATOR TAPE2003-07-17

Injury

2,704

Other

2

Total

2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1681-2026 — 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)Class II·Ongoing·Mentor Texas, LP.·20260218
• Z-2747-2016 — 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 temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.Class II·Terminated·Mentor Texas, LP.·20160809
• Z-2748-2016 — 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 temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.Class II·Terminated·Mentor Texas, LP.·20160809
• Z-2781-2016 — 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 procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.Class II·Terminated·Mentor Texas, LP.·20160809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130813.