# K151548: VersaOne Bladed Trocar, VersaOne Bladeless Trocar

- Pathway: 510(k) (Special)
- Applicant: Covidien
- Decided: Jul 2, 2015 after 23 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 K011257 (2001). 6 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062326: Autosuture Modified Versaport Trocar with Fixation Sleeve, United States Surgical, A Division of Tyco Healthc (2006) Summary page 4.
- K081169: Autosuture Versaport Plus Bladless Trocar; Bladeless Trocar, Covidien Lp, Formerly Registered AS United States (2008) Summary page 4.
- K130435: Versaport V2 Bladeless Optical Trocar, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 4.

## Most influential descendants
- K163654: VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar (2017), 1 descendant of its own
- K162584: VersaOne Bladeless Trocar (2016), 1 descendant of its own
- K252532: Inno-Port Disposable Bladed Trocar (2026), 0 descendants of its own
- K260197: Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) (2026), 0 descendants of its own
- K223593: Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar (2023), 0 descendants of its own

## Indications for use
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/K151548
Methodology: https://510kreport.com/methodology