# K212214: HandX

- Pathway: 510(k) (Traditional)
- Applicant: Human Xtensions, Ltd.
- Decided: Sep 13, 2021 after 60 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: 6 generations back to K912544 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 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 4.
- K203603: Monopolar Hook, Human Xtensions, Ltd. (2021) Summary page 4.

## Indications for use
The HandX is intended to assist in the control of Human Xtensions laparoscopic instruments including needle holder, grasper and monopolar instruments, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, cutting and/or coagulation, during laparoscopic surgical procedures. The HandX monopolar instruments are connected by a standard cable to a standard electrosurgical power source. It is intended to be used by trained physicians in an operating room environment in accordance with its Instructions for Use.

Source page: https://510kreport.com/device/K212214
Methodology: https://510kreport.com/methodology