# K193272: GTK Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou T.K Medical Instrument Co., Ltd.
- Decided: Jul 9, 2020 after 226 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 K920110 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112358: Unimax Trocar System, Unimax Medical Systems, Inc. (2011) Summary page 5.

## Indications for use
The GTK Trocars has an application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments.

Source page: https://510kreport.com/device/K193272
Methodology: https://510kreport.com/methodology