# K191762: Magnetic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Levita Magnetics International Corp
- Decided: Apr 1, 2020 after 275 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: 4 generations back to DEN150007 (2016). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190006: Magnetic Surgical System, Levita Magnetics International Corp (2019) Summary page 5.

## Most influential descendants
- K250746: Magnetic Surgical System (2025), 1 descendant of its own
- K252435: Magnetic Surgical System (2025), 0 descendants of its own

## Indications for use
The Levita Magnetic Surgical System is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures; the liver in bariatric procedures; the prostate and periprostatic tissue in prostatectomy procedures; and the colon, rectum, and pericolorectal tissue in colorectal procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients with a BMI range of 20-60-kg/m2.

Source page: https://510kreport.com/device/K191762
Methodology: https://510kreport.com/methodology