FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
Symani Surgical System
K Number: K251510
·
Decision Sep 4, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
4
Applicant Total
4
Review Days
111
Basic Information
- Device Name
- Symani Surgical System
- K Number
- K251510
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4963
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medical Microinstruments, Inc.
- Date Received
- May 16, 2025
- Decision Date
- September 4, 2025
- Product Code
- SAQ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| SAQ | Electromechanical System For Open Microsurgery | FDA class 2 | General, Plastic Surgery |
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