FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MagDI System
K Number: DEN240013
·
Decision Jul 2, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
4
Review Days
98
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Basic Information
- Device Name
- MagDI System
- K Number
- DEN240013
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 878.4816
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Applicant
- Gt Metabolic Solutions, Inc.
- Date Received
- March 26, 2024
- Decision Date
- July 2, 2024
- Product Code
- SAH
- 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 |
|---|---|---|---|
| SAH | Magnetic Compression Anastomosis System | FDA class 2 | General, Plastic Surgery |
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