FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Artoura Breast Tissue Expander
K Number: K150777
·
Decision Apr 24, 2015
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- Artoura Breast Tissue Expander
- K Number
- K150777
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Worldwide, LLC
- Date Received
- March 25, 2015
- Decision Date
- April 24, 2015
- 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.
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Motiva Flora SmoothSilk Tissue Expander
FDA 510(k)
FDA Unclassified
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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 |
| K182335 | CPX 4 Breast Tissue Expander with Smooth Surface | Sep 25, 2018 | 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 |
| K142998 | CPX Control Breast Tissue Expander | Dec 19, 2014 | Substantially Equivalent |