MENTOR CPX4 PLUS Enhance Breast Tissue Expander— 510(k) K241918
Substantially EquivalentMentor Worldwide, LLC
FDA 510(k) clearance K241918 for MENTOR CPX4 PLUS Enhance Breast Tissue Expander, Substantially Equivalent on 2024-08-02. Applicant: Mentor Worldwide, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Mentor Worldwide, LLC
- Product code
- Code LCJ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Irvine, CA, US
Recent devices under product code LCJ
view allMore clearances from Mentor Worldwide, LLC
view allAdverse events under product code LCJ
product code LCJ- Injury
- 2,704
- Other
- 2
- Total
- 2,706
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K241918
K-number listed on FDA's recall record- Z-1682-2026 — CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc
- Z-1683-2026 — 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, 550cc, 650cc, 800cc
- Z-1684-2026 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K241918.
Data sourced from openFDA. This site is unofficial and independent of the FDA.