# K172796: Flex Robotic System and Flex Transabdominal Drive

- Pathway: 510(k) (Traditional)
- Applicant: Medrobotics Corporation
- Decided: Jan 18, 2018 after 125 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931154 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
3 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123365: Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190, Olympus Medical Systems Corp. (2013) Summary page 4.

## Indications for use
The Medrobotics Flex® Robotic System is intended to provide robot-assisted control of the Flex® Transabdominal Drive. The Flex® Transabdominal Drive is intended to be used with ancillary equipment for endoscopy and endoscopic surgery. The Flex® Transabdominal Drive is indicated to provide robot-assisted visualization within the thoracic and abdominal cavities including female reproductive organs. This instrument must not be used for observation or treatment of the heart and must not contact the heart or any area near the heart. This instrument must not come into contact with any device or therapeutic accessory that contacts the heart or any area near the heart.

Source page: https://510kreport.com/device/K172796
Methodology: https://510kreport.com/methodology