# K230491: HandX™ Monopolar Scissors

- Pathway: 510(k) (Traditional)
- Applicant: Human Xtensions, Ltd.
- Decided: May 10, 2023 after 76 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)
- 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/K230491
Methodology: https://510kreport.com/methodology