# K190006: Magnetic Surgical System

- Pathway: 510(k) (Traditional)
- Applicant: Levita Magnetics International Corp
- Decided: Apr 29, 2019 after 117 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: 3 generations back to DEN150007 (2016). 3 ancestors in all.
3 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)
- K180894: Magnetic Surgical System, Levita Magnetics International Corp (2018) Summary page 4.
- DEN150007: Magnetic Surgical System, Levita Magnetics International Corp (2016) Summary page 4.

## Most influential descendants
- K191762: Magnetic Surgical System (2020), 2 descendants of its own
- 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, and the prostate and periprostatic tissue in prostatectomy 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/K190006
Methodology: https://510kreport.com/methodology