# K203603: Monopolar Hook

- Pathway: 510(k) (Traditional)
- Applicant: Human Xtensions, Ltd.
- Decided: Feb 1, 2021 after 54 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 K912544 (1991). 22 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 26 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.
- K091869: Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears, Covidien Lp, Formerly Registered AS United States (2009) Summary page 4.

## Most influential descendants
- K230491: HandX™ Monopolar Scissors (2023), 0 descendants of its own
- K222011: HandX Instrument - Monopolar Spatula (2023), 0 descendants of its own
- K212214: HandX (2021), 0 descendants of its own

## 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/K203603
Methodology: https://510kreport.com/methodology