# K223562: Xpan Universal Trocar System

- Pathway: 510(k) (Traditional)
- Applicant: Xpan, Inc.
- Decided: Jun 2, 2023 after 186 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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 K940232 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012539: Verastep, United States Surgical, A Division of Tyco Healthc (2001) Summary page 4.

## Indications for use
The Xpan Universal Trocar System is intended to provide dilation access with or without visualization to the abdominal and thoracic cavities for performing diagnostic and operative abdominal and thoracic procedures. Laparoscopic access to the abdominal cavity, both primary and secondary punctures. Thoracoscopic access to the thoracic cavity, both primary and secondary punctures.

Source page: https://510kreport.com/device/K223562
Methodology: https://510kreport.com/methodology