FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Magnetic Surgical System
K Number: K250746
·
Decision Jun 7, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
7
Applicant Total
8
Review Days
87
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Basic Information
- Device Name
- Magnetic Surgical System
- K Number
- K250746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4815
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Levita Magnetics International Corp
- Date Received
- March 12, 2025
- Decision Date
- June 7, 2025
- Product Code
- PNL
- 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 |
|---|---|---|---|
| PNL | Magnetic Surgical System | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PNL), ordered by most recent decision date.
Magnetic Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Surgeon Controlled Arm
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Magnetic Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Magnetic Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Magnetic Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Magnetic Surgical System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Levita Magnetics International Corp
| K Number | Device Name | ||
|---|---|---|---|
| K252435 | Magnetic Surgical System | Sep 26, 2025 | Substantially Equivalent |
| K223673 | Surgeon Controlled Arm | Aug 4, 2023 | Substantially Equivalent |
| K191762 | Magnetic Surgical System | Apr 1, 2020 | Substantially Equivalent |
| K190006 | Magnetic Surgical System | Apr 29, 2019 | Substantially Equivalent |
| K180894 | Magnetic Surgical System | Sep 19, 2018 | Substantially Equivalent |
| K171429 | Magnetic Surgical System | Jun 6, 2017 | Substantially Equivalent |
| DEN150007 | Magnetic Surgical System | Jun 13, 2016 | Unknown |