# K201805: VersaOne Reusable Positioning Trocar System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Aug 26, 2020 after 56 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K011257 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130435: Versaport V2 Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 4.
- K162584: VersaOne Bladeless Trocar, Covidien (2016) Summary page 4.

## Recalls of this device
- Mar 22, 2023 · Class II · Z-1464-2023: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welde
- Mar 22, 2023 · Class II · Z-1465-2023: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welde
- Mar 22, 2023 · Class II · Z-1463-2023: There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welde

## Indications for use
The VersaOne™ reusable positioning trocar system is intended for use in a variety of gynecologic, general, thoracic and urological endoscopic procedures to create and maintain a port of entry. The 11mm and 12 mm trocar may be used with or without visualization for primary and secondary insertions.

Source page: https://510kreport.com/device/K201805
Methodology: https://510kreport.com/methodology