ARTOURA Breast Tissue Expanders with Smooth Surface— 510(k) K161176
Substantially EquivalentMentor Worldwide, LLC
FDA 510(k) clearance K161176 for ARTOURA Breast Tissue Expanders with Smooth Surface, Substantially Equivalent on 2016-05-23. 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
- Irvin, CA, US
Recent devices under product code LCJ
view allMore clearances from Mentor Worldwide, LLC
view all- K243271 — MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer +2 more
- K241552 — MENTOR MemoryGel Enhance Single Use Gel Sizer
- K182335 — CPX 4 Breast Tissue Expander with Smooth Surface
- K152496 — CPX 4 Breast Tissue Expander
- K151055 — Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
Adverse 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 K161176
K-number listed on FDA's recall record- Z-1686-2026 — Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc
- Z-1687-2026 — Artoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH SDC-135UH SDC-140UH Smooth Ultra High Profile Tissue Expander, 350cc, 455cc, 535cc, 650cc, 700cc, 850cc
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161176.
Data sourced from openFDA. This site is unofficial and independent of the FDA.