510(k) K252435
- Device
- Magnetic Surgical System
- Applicant
- Levita Magnetics International Corp
- 510(k) number
- K252435
- Product code
- PNL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-09-26
- Date received
- 2025-08-01
- Regulation
- 878.4815
- Classification name
- Magnetic Surgical System
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Donielle Baudin
- Address
- 453 Ravendale Dr. Mountain View CA US 94063 94063
FDA Registration Numbers#
- 2219920
- 3012986524
- 2953359
- 3008791915
Source Documents#
Other 510(k) Records For Product Code PNL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250746 | Magnetic Surgical System | Levita Magnetics International Corp | 2025-06-07 |
| K223673 | Surgeon Controlled Arm | Levita Magnetics International Corp | 2023-08-04 |
| K191762 | Magnetic Surgical System | Levita Magnetics International Corp | 2020-04-01 |
| K190006 | Magnetic Surgical System | Levita Magnetics International Corp | 2019-04-29 |
| K180894 | Magnetic Surgical System | Levita Magnetics International Corp | 2018-09-19 |
| K171429 | Magnetic Surgical System | Levita Magnetics International Corp | 2017-06-06 |
| DEN150007 | Magnetic Surgical System | Levita Magnetics International Corp | 2016-06-13 |