# K160230: VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Mar 1, 2016 after 29 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.
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)
- K130435: Versaport V2 Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 4.
- 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.

## Indications for use
The VersaOne™ optical trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry. The trocar may be used with or without visualization for primary and secondary insertions. 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/K160230
Methodology: https://510kreport.com/methodology