Magnetic Surgical System
FDA 510(k) clearance K250746 · decided 2025-06-07
Clearance details
- K-number
- K250746
- Device name
- Magnetic Surgical System
- Applicant
- Levita Magnetics International Corp
- Decision
- Substantially Equivalent
- Date received
- 2025-03-12
- Decision date
- 2025-06-07
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- PNL
- Device class
- 2
- Regulation number
- 878.4815
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Magnetic Surgical System (K252435) | Levita Magnetics International Corp | 2025-09-26 |
| Surgeon Controlled Arm (K223673) | Levita Magnetics International Corp | 2023-08-04 |
| Magnetic Surgical System (K191762) | Levita Magnetics International Corp | 2020-04-01 |
| Magnetic Surgical System (K190006) | Levita Magnetics International Corp | 2019-04-29 |
| Magnetic Surgical System (K180894) | Levita Magnetics International Corp | 2018-09-19 |
| Magnetic Surgical System (K171429) | Levita Magnetics International Corp | 2017-06-06 |
| Magnetic Surgical System (DEN150007) | Levita Magnetics International Corp | 2016-06-13 |
Recalls involving this device
No recalls on record reference this clearance.