FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
Sientra, inc. Portfinder
K Number: K221127
·
Decision May 10, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
54
Applicant Total
3
Review Days
387
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Basic Information
- Device Name
- Sientra, inc. Portfinder
- K Number
- K221127
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sientra, Inc.
- Date Received
- April 18, 2022
- Decision Date
- May 10, 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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