FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
K Number: K243271
·
Decision Jan 13, 2025
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
12
Applicant Total
12
Review Days
89
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Basic Information
- Device Name
- MENTOR MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
- K Number
- K243271
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mentor Worldwide, LLC
- Date Received
- October 16, 2024
- Decision Date
- January 13, 2025
- Product Code
- MRD
- 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 |
|---|---|---|---|
| MRD | Mammary Sizer | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MRD), ordered by most recent decision date.
MENTOR MemoryGel Enhance Single Use Gel Sizer
FDA 510(k)
FDA Unclassified
·Unknown
NATRELLE INSPIRA Single Use Sizers for Gel Implants
FDA 510(k)
FDA Unclassified
·Unknown
Sientra OPUS Silicone Gel Breast Implant Sizer
FDA 510(k)
FDA Unclassified
·Unknown
Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix
FDA 510(k)
FDA Unclassified
·Unknown
Mentor MemoryShape Resterilizable Gel Breast Implant Sizer STERILE
FDA 510(k)
FDA Unclassified
·Unknown
MENTOR MEMORYSHAPE RESTERILIZABLE GEL SIZER
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 |
| 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 |
| K150777 | Artoura Breast Tissue Expander | Apr 24, 2015 | Substantially Equivalent |
| K142998 | CPX Control Breast Tissue Expander | Dec 19, 2014 | Substantially Equivalent |