FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Motiva Flora SmoothSilk Tissue Expander
K Number: K211676
·
Decision Oct 13, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
2
Review Days
864
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Basic Information
- Device Name
- Motiva Flora SmoothSilk Tissue Expander
- K Number
- K211676
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Motiva USA, LLC
- Date Received
- June 1, 2021
- Decision Date
- October 13, 2023
- 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 |
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Other Clearances by Motiva USA, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K183163 | Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix | Feb 5, 2019 | Substantially Equivalent |