# K223673: Surgeon Controlled Arm

- Pathway: 510(k) (Traditional)
- Applicant: Levita Magnetics International Corp
- Decided: Aug 4, 2023 after 240 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: 5 generations back to K931783 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171947: Soloassist II, Aktormed GmbH (2018) Summary page 4.

## Indications for use
The Surgeon Controlled Arm is indicated for use to hold and position a rigid laparoscope/endoscope and the Magnetic Controller of the Levita Magnetic Surgical System in minimally invasive interventions where the Levita Magnetic Surgical System is indicated for use.

Source page: https://510kreport.com/device/K223673
Methodology: https://510kreport.com/methodology