# K173919: HX Device

- Pathway: 510(k) (Traditional)
- Applicant: Human Extension, Ltd.
- Decided: Mar 20, 2018 after 88 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: 4 generations back to K912544 (1991). 15 ancestors in all.
8 later devices descend from it; 6 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector,  Model PW1201-01;Purewrist Hook, Model PW1301-01, Cambridge Endoscopic Devices (2006) Summary page 4.
- K123102: Sovereign Mini, Aesculap, Inc. (2013) Summary page 4.

## Most influential descendants
- K203603: Monopolar Hook (2021), 3 descendants of its own
- K260183: MediBot Needle Driver Uno (2026), 0 descendants of its own
- K243968: Revolve Surgical System (2025), 0 descendants of its own
- K244029: Robopera (ER-R-002); Robopera (ER-R-003) (2025), 0 descendants of its own
- K223718: HandX™ Self-Righting Needle Holder (2023), 0 descendants of its own

## Indications for use
The HX Device is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for endoscopic manipulation of tissue, including grasping, approximation, ligation, suturing, during laparoscopic surgical procedures. 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/K173919
Methodology: https://510kreport.com/methodology