510(k) K130813 ยท LCJ Tissue Expander And Accessories
MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERS
| Applicant | Mentor Corp., Santa Barbara CA, US |
| Decision | Substantially Equivalent, Apr 11, 2013 |
| Received | Mar 25, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.