CPX 4 Breast Tissue Expander with Smooth Surface— 510(k) K182335
Substantially EquivalentMentor Worldwide, LLC
FDA 510(k) clearance K182335 for CPX 4 Breast Tissue Expander with Smooth Surface, Substantially Equivalent on 2018-09-25. 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
- K161176 — ARTOURA Breast Tissue Expanders 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.