# K162584: VersaOne Bladeless Trocar

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Oct 18, 2016 after 32 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: 4 generations back to K011257 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151548: VersaOne Bladed Trocar, VersaOne Bladeless Trocar, Covidien (2015) Summary page 4.
- K081169: Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar, Covidien Lp, Formerly Registered AS United States (2008) Summary page 4.

## Most influential descendants
- K201805: VersaOne Reusable Positioning Trocar System (2020), 0 descendants of its own

## Indications for use
The VersaOne™ bladeless trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.

Source page: https://510kreport.com/device/K162584
Methodology: https://510kreport.com/methodology