FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Sientra OPUS Silicone Gel Breast Implant Sizer
K Number: K200706
·
Decision Nov 16, 2020
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
12
Applicant Total
3
Review Days
243
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Basic Information
- Device Name
- Sientra OPUS Silicone Gel Breast Implant Sizer
- K Number
- K200706
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sientra, Inc.
- Date Received
- March 18, 2020
- Decision Date
- November 16, 2020
- 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 MemoryShape Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Resterilizable Gel Breast Implant Sizer; MENTOR MemoryGel Enhance Single Use Gel Sizer
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FDA Unclassified
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MENTOR MemoryGel Enhance Single Use Gel Sizer
FDA 510(k)
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NATRELLE INSPIRA Single Use Sizers for Gel Implants
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