# K252435: Magnetic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Levita Magnetics International Corp
- Decided: Sep 26, 2025 after 56 days
- Product code: PNL (Magnetic Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4815
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN150007 (2016). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250746: Magnetic Surgical System, Levita Magnetics International Corp (2025) Summary page 5.

## Indications for use
The Magnetic Surgical System is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following: -The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures -The liver in bariatric procedures -The prostate and periprostatic tissue in prostatectomy procedures -The colon, rectum, and pericolorectal tissue in colorectal procedures The Grasper Tip 12.5 is indicated for use in patients within a BMI range of 20 to 60 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following -The pillar of the diaphragm and peripillar tissue in bariatric or hiatal hernia procedures Pediatric use: The Magnetic Surgical System is indicated for use in adolescents (12-21) within a BMI range of 20 to 34 kg/m2 and designed to grasp and retract soft tissues and organs to facilitate access and visualization of the surgical site for the following: -The body and fundus of the gallbladder in laparoscopic cholecystectomy procedures

Source page: https://510kreport.com/device/K252435
Methodology: https://510kreport.com/methodology