510(k) K150777 ยท LCJ Tissue Expander And Accessories
Artoura Breast Tissue Expander
| Applicant | Mentor Worldwide, LLC, Santa Barbara CA, US |
| Decision | Substantially Equivalent, Apr 24, 2015 |
| Received | Mar 25, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Mentor Texas, LP. Artoura Breast Tissue Expanders
Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH
Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 53 Open, Classified |
LCJ | None listed |
| Sep 10, 2016 | Mentor Texas, LP. 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 p Terminated |
LCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.