PNL

Magnetic Surgical System

Product code

PNL

Device name

Magnetic Surgical System

Device class

Class 2

21 CFR

21 CFR 878.4815

Medical specialty

General, Plastic Surgery

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

8 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-26.

2 summaries are archived here for direct download.