DeviceClearance

Product code PNL— General, Plastic Surgery

Magnetic Surgical System

Device class
Class 2
Regulation
21 CFR 878.4815
Advisory panel
General, Plastic Surgery
Total cleared
8
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PNL under 21 CFR 878.4815, via openFDA

Market context for product code PNL

FDA has cleared 8 devices under product code PNL between 2016 and 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PNL

Recent clearances under product code PNL

Data sourced from openFDA. This site is unofficial and independent of the FDA.