PNL
8 FDA 510(k) clearances · Product code
167 daysmedian time to decision
489 days90th percentile
8clearances measured
FDA profile
- Official device name
- Magnetic Surgical System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4815
- Medical specialty
- General, Plastic Surgery
- FDA definition
- System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Magnetic Surgical System (K252435) | Levita Magnetics International Corp | 2025-09-26 |
| Magnetic Surgical System (K250746) | Levita Magnetics International Corp | 2025-06-07 |
| 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 |
Track PNL automatically
Every clearance here is in the API, with alerts when new ones post.