# K233263: Disposable Trocars

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Kangji Medical Instrument Co., Ltd.
- Decided: Apr 9, 2024 after 193 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: 7 generations back to K940232 (1994). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 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 6.
- K211577: SoftFix Balloon Trocar, Unimax Medical Systems, Inc. (2021) Summary page 6.
- K141715: Glove Port, Nelis (2015) Summary page 6.
- K093372: Sils Port Model SILSPT15, Covidien Lp, Formerly Registered AS Tyco Healthcar (2009) Summary page 6.
- K073719: Asc Triport Laparoscopic Access Device, Advanced Surgical Concepts (2008) Summary page 6.

## Indications for use
The Disposable Trocars have application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments and/or endoscope.

Source page: https://510kreport.com/device/K233263
Methodology: https://510kreport.com/methodology