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PNL — Magnetic Surgical System Class II

FDA Device Classification

Classification Details

Product Code
PNL
Device Class
Class II
Regulation Number
878.4815
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K252435levita magnetics internationalMagnetic Surgical SystemSeptember 26, 2025
K250746levita magnetics internationalMagnetic Surgical SystemJune 7, 2025
K223673levita magnetics internationalSurgeon Controlled ArmAugust 4, 2023
K191762levita magnetics internationalMagnetic Surgical SystemApril 1, 2020
K190006levita magnetics internationalMagnetic Surgical SystemApril 29, 2019
K180894levita magnetics internationalMagnetic Surgical SystemSeptember 19, 2018
K171429levita magnetics internationalMagnetic Surgical SystemJune 6, 2017
DEN150007levita magnetics internationalMagnetic Surgical SystemJune 13, 2016