FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
CPX 4 Breast Tissue Expander with Smooth Surface
K Number: K182335
·
Decision Sep 25, 2018
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- CPX 4 Breast Tissue Expander with Smooth Surface
- K Number
- K182335
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Worldwide, LLC
- Date Received
- August 28, 2018
- Decision Date
- September 25, 2018
- Product Code
- LCJ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCJ | Tissue Expander And Accessories | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LCJ), ordered by most recent decision date.
Natrelle 133S Tissue Expanders
FDA 510(k)
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MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs
FDA 510(k)
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Mentor CPX 4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR CPX4 PLUS Enhance Breast Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
·Unknown
AlloX2 Pro Tissue Expanders
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Mentor Worldwide, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K242963 | MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs | Apr 24, 2025 | Substantially Equivalent |
| K243271 | MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer | Jan 13, 2025 | Substantially Equivalent |
| K243836 | Mentor CPX 4 PLUS Enhance Breast Tissue Expander | Jan 12, 2025 | Substantially Equivalent |
| K241552 | MENTOR MemoryGel Enhance Single Use Gel Sizer | Sep 6, 2024 | Substantially Equivalent |
| K241918 | MENTOR CPX4 PLUS Enhance Breast Tissue Expander | Aug 2, 2024 | Substantially Equivalent |
| K161176 | ARTOURA Breast Tissue Expanders with Smooth Surface | May 23, 2016 | Substantially Equivalent |
| K152496 | CPX 4 Breast Tissue Expander | Feb 19, 2016 | Substantially Equivalent |
| K151055 | Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE | May 20, 2015 | Substantially Equivalent |
| K150777 | Artoura Breast Tissue Expander | Apr 24, 2015 | Substantially Equivalent |
| K142998 | CPX Control Breast Tissue Expander | Dec 19, 2014 | Substantially Equivalent |