Artoura Breast Tissue Expander— 510(k) K150777
Substantially EquivalentMentor Worldwide, LLC
FDA 510(k) clearance K150777 for Artoura Breast Tissue Expander, Substantially Equivalent on 2015-04-24. 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
- Santa Barbara, 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 K150777
K-number listed on FDA's recall record- Z-1685-2026 — Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,
- Z-2780-2016 — 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 procedures. The devices are intended for temporary subcutaneous or sub muscular implantation and are not intended for use beyond six months.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150777.
Data sourced from openFDA. This site is unofficial and independent of the FDA.