# K190029: Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar

- Pathway: 510(k) (Traditional)
- Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
- Decided: Sep 26, 2019 after 262 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). 3 ancestors in all.
5 later devices descend from it; 4 cite 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)
- K122511: Endopath Xcel Bladeless Trocar with Optiview Technology Endopath Xcel Blunt Tip Trocar with Optiview Technology Endopath, Ethicon Endo-Surgery, LLC (2012) Summary page 5.
- K062326: Autosuture Modified Versaport Trocar with Fixation Sleeve, United States Surgical, A Division of Tyco Healthc (2006). Our reading of the summary gave K062362, FDA’s number for Single Use Esophageal Manometey Catheters and Single Use… (Sarmed Srl). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Autosuture Modified Versaport Trocar with Fixation Sleeve”. Summary page 7.

## Most influential descendants
- K222695: troCarWash™ System (2023), 1 descendant of its own
- K250820: Disposable Trocars (2025), 0 descendants of its own
- K233386: Monik™ - Disposable Endoscopic Trocar (2024), 0 descendants of its own
- K233442: troCarWash™ System (2024), 0 descendants of its own
- K231042: Disposable Laparoscopic Trocar (2023), 0 descendants of its own

## Indications for use
The devices, Disposable Bladeless Trocar, Disposable Optical Trocar and Disposable Bladed Trocar, have applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments.

Source page: https://510kreport.com/device/K190029
Methodology: https://510kreport.com/methodology