# K171429: Magnetic Surgical System

- Pathway: 510(k) (Special)
- Applicant: Levita Magnetics International Corp
- Decided: Jun 6, 2017 after 22 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: 1 generation back to DEN150007 (2016). 1 ancestor in all.
5 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)
- DEN150007: Magnetic Surgical System, Levita Magnetics International Corp (2016) Summary page 4.

## Most influential descendants
- K180894: Magnetic Surgical System (2018), 4 descendants of its own
- K190006: Magnetic Surgical System (2019), 3 descendants of its own
- 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 Magnetic Surgical System is 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.

Source page: https://510kreport.com/device/K171429
Methodology: https://510kreport.com/methodology