# K244029: Robopera (ER-R-002); Robopera (ER-R-003)

- Pathway: 510(k) (Traditional)
- Applicant: Endorobotics Co., Ltd.
- Decided: Sep 24, 2025 after 268 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- 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: 5 generations back to K912544 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173919: HX Device, Human Extension, Ltd. (2018) Summary page 7.

## Indications for use
The ROBOPERA is intended to hold and lift the tissue and mucosal membrane within the esophagus, stomach, colon, and rectum of the gastrointestinal tract, excluding the small intestine, during endoscopic surgical procedures. It is intended to be used by trained physicians in a hospital.

Source page: https://510kreport.com/device/K244029
Methodology: https://510kreport.com/methodology