# K212736: Canady Flex RoboWrist

- Pathway: 510(k) (Traditional)
- Applicant: Us Medical Innovations, LLC
- Decided: Nov 22, 2022 after 449 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: 5 generations back to K910831 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072715: Realhand High Dexterity Instruments, Novare Surgical Systems, Inc. (2007) Summary page 5.

## Indications for use
The Canady Flex RoboWrist is intended for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization.

Source page: https://510kreport.com/device/K212736
Methodology: https://510kreport.com/methodology