FDA product code PNL: Magnetic Surgical System
PNL is the FDA product code for magnetic surgical system. It is a Class II device, regulated under 21 CFR 878.4815 and reviewed by the General and Plastic Surgery panel. FDA has cleared 7 510(k) submissions under PNL, 3 in the last five years. The average 510(k) review took 138 days (median 117); 72 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Magnetic Surgical System |
| Device class | Class II |
| Regulation | 21 CFR 878.4815 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for PNL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 22 |
| 2018 | 1 | 167 |
| 2019 | 1 | 117 |
| 2020 | 1 | 275 |
| 2023 | 1 | 240 |
| 2025 | 2 | 72 |
Compare with all 510(k) review times · Search every PNL clearance
Top PNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Levita Magnetics International Corp | 7 | 2025-09-26 |
Most recent PNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252435 | Levita Magnetics International Corp | Magnetic Surgical System | 2025-09-26 | 56 |
| K250746 | Levita Magnetics International Corp | Magnetic Surgical System | 2025-06-07 | 87 |
| K223673 | Levita Magnetics International Corp | Surgeon Controlled Arm | 2023-08-04 | 240 |
| K191762 | Levita Magnetics International Corp | Magnetic Surgical System | 2020-04-01 | 275 |
| K190006 | Levita Magnetics International Corp | Magnetic Surgical System | 2019-04-29 | 117 |
Recalls for PNL devices
openFDA lists no recalls for product code PNL.
Frequently asked questions
What is FDA product code PNL?
PNL is the FDA product code for magnetic surgical system. It is a Class II device, regulated under 21 CFR 878.4815 and reviewed by the General and Plastic Surgery panel.
What device class is PNL?
Class II, regulation 21 CFR 878.4815. Typical premarket route: 510(k).
How long does a 510(k) take for product code PNL?
Across 7 cleared submissions the average was 138 days from receipt to decision (median 117).
Which companies have the most PNL clearances?
Levita Magnetics International Corp (7).
Next steps
- Run an FDA pathway report with predicate devices for product code PNL
- Run a recall and safety report across every PNL manufacturer
- Watch product code PNL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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