# K162330: Flex Robotic System and Flex Colorectal Drive

- Pathway: 510(k) (Traditional)
- Applicant: Medrobotics Corporation
- Decided: May 4, 2017 after 258 days
- Product code: FDF (Colonoscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921244 (1992). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070622: Neoguide Endoscopy System, Neoguide Systems, Inc. (2007) Summary page 4.

## Most influential descendants
- K172036: Medrobotics Flex Robotic System (2017), 0 descendants of its own

## Recalls of this device
- Jan 25, 2019 · Class II · Z-1192-2019: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.
- Jan 25, 2019 · Class II · Z-1191-2019: The weld may break, resulting in the rod separating from the cone of the long and short cone Obturators.

## Indications for use
The Medrobotics Flex Robotic System is intended to provide robot-assisted control of the Flex Colorectal Drive during visualization of and surgical site access to the anus, rectum and distal colon. The Flex Robotic System is intended for use in adults (≥22 years of age). The Flex Colorectal Drive is intended for robot-assisted visualization of and surgical site access to the anus, rectum, and distal colon in adults (≥22 years of age). The Flex Colorectal Drive also provides accessory channels for compatible flexible instruments used in surgery.

Source page: https://510kreport.com/device/K162330
Methodology: https://510kreport.com/methodology