Product code PNL

Device name

Magnetic Surgical System

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4815

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset