PNL — Magnetic Surgical System Class II
FDA product code PNL covers "Magnetic Surgical System", a Class II medical device regulated under 21 CFR 878.4815. Submissions are reviewed by the General, Plastic Surgery panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PNL
- Device Class
- Class II
- Regulation Number
- 878.4815
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252435 | Levita Magnetics International | Magnetic Surgical System | Sep 26, 2025 |
| K250746 | Levita Magnetics International | Magnetic Surgical System | Jun 7, 2025 |
| K223673 | Levita Magnetics International | Surgeon Controlled Arm | Aug 4, 2023 |
| K191762 | Levita Magnetics International | Magnetic Surgical System | Apr 1, 2020 |
| K190006 | Levita Magnetics International | Magnetic Surgical System | Apr 29, 2019 |
| K180894 | Levita Magnetics International | Magnetic Surgical System | Sep 19, 2018 |
| K171429 | Levita Magnetics International | Magnetic Surgical System | Jun 6, 2017 |
| DEN150007 | Levita Magnetics International | Magnetic Surgical System | Jun 13, 2016 |