510(k) K241918 · LCJ Tissue Expander And Accessories
MENTOR CPX4 PLUS Enhance Breast Tissue Expander
| Applicant | Mentor Worldwide, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 2, 2024 |
| Received | Jul 1, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241918
| 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: SCPX-157LH
Smooth Low Height Tissue Expander, 650cc Open, Classified |
LCJ | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.