# K213818: VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jun 27, 2022 after 202 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: 2 generations back to K011257 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112349: Versaport V2 Bladeless Optiical Trocar and/or Versaport Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2011) Summary page 4.

## Indications for use
The VersaOne™ optical trocar with fixation balloon cannula is indicated for use in general, gynecologic, thoracic and urologic minimally invasive surgical procedures. The intended purpose of the device is to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K213818
Methodology: https://510kreport.com/methodology