Mentor Worldwide, LLC
Santa Barbara, CA, US
Mentor Worldwide, LLC appears in FDA device records in Santa Barbara, CA. FDA records list 12 510(k) clearances between and , 116 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 12
- PMA records
- 116
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 12 510(k) clearances for Mentor Worldwide, LLC between 2013 and 2025. The busiest year on record is 2025, with 3. The most recent is 2025, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2018 | 1 |
| 2024 | 2 |
| 2025 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242963 | MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs | LCJ | Substantially Equivalent | |
| K243271 | MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Resterilizable Gel Breast Implant Sizer; MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | MRD | Substantially Equivalent | |
| K243836 | Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander | LCJ | Substantially Equivalent | |
| K241552 | MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer | MRD | Substantially Equivalent | |
| K241918 | MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander | LCJ | Substantially Equivalent | |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | LCJ | Substantially Equivalent | |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | LCJ | Substantially Equivalent | |
| K152496 | CPX 4 Breast Tissue Expander | LCJ | Substantially Equivalent | |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | MRD | Substantially Equivalent | |
| K150777 | Artoura Breast Tissue Expander | LCJ | Substantially Equivalent | |
| K142998 | CPX Control Breast Tissue Expander | LCJ | Substantially Equivalent | |
| K131853 | MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER | MRD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain