# K231725: Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R)

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Endoso Life Technology Co., Ltd.
- Decided: Oct 16, 2023 after 125 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 K993045 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201151: O-Mec 690 Series Laparoscopes, Omec Medical, Inc. (2020) Summary page 5.

## Indications for use
It is used in medical institutions for observation and imaging in abdominal surgery by entering the human body through the wound.

Source page: https://510kreport.com/device/K231725
Methodology: https://510kreport.com/methodology