PNLClass II
Magnetic Surgical System
21 CFR 878.4815 / General, Plastic Surgery
PNL is the FDA product code for Magnetic Surgical System, a class II device type, regulated under 21 CFR 878.4815. FDA's definition for this code reads: "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". As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PNL
- Device name
- Magnetic Surgical System
- 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.
- Regulation
- 21 CFR 878.4815
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 8
- Ingested recalls
- 0
Clearances, product code PNL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2025 | 2 |
Applicants with the most clearances
Product code PNL| Applicant | Clearances |
|---|---|
| Levita Magnetics International Corp. | 8 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.