# DEN150007: Magnetic Surgical System

- Pathway: De Novo (Direct)
- Applicant: Levita Magnetics International Corp
- Decided: Jun 13, 2016 after 489 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
No predicates in its family tree.
6 later devices descend from it; 3 cite 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)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K171429: Magnetic Surgical System (2017), 5 descendants of its own
- 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

## Indications for use
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/DEN150007
Methodology: https://510kreport.com/methodology