# K172036: Medrobotics Flex Robotic System

- Pathway: 510(k) (Special)
- Applicant: Medrobotics Corporation
- Decided: Aug 3, 2017 after 29 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: 8 generations back to K921244 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162330: Flex Robotic System and Flex Colorectal Drive, Medrobotics Corporation (2017) Summary page 4.

## 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/K172036
Methodology: https://510kreport.com/methodology