# K162387: U-IGNITE Bladeless Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Tianjin Uwell Medical Device Manufacturing Co., Ltd.
- Decided: Jan 11, 2017 after 139 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 K032676 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath, Ethicon Endo-Surgery, LLC (2012) Summary page 4.

## Most influential descendants
- K202931: Disposable Trocar (2020), 0 descendants of its own

## Indications for use
The U-IGNITE Bladeless Trocar has applications in endoscopic procedures to provide a port of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K162387
Methodology: https://510kreport.com/methodology