# K254174: Surgical Power System

- Pathway: 510(k) (Traditional)
- Applicant: Guizhou Zirui Technology Co., Ltd.
- Decided: Sep 11, 2026 after 262 days
- Product code: HBC (Motor, Drill, Electric)
- Device class: 2
- Regulation: 21 CFR 882.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K862807 (1986). 68 ancestors in all.
No later device cites it as a predicate yet.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170312: IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools, Medtronic Powered Surgical Solutions (2017) Summary page 6.
- K231403: evoDrill Cranial Perforator, Evonos GmbH & Co. KG (2024) Summary page 6.

## Indications for use
The Surgical Power System is an electrically operated surgical instrument system. The handpiece provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery.

Source page: https://510kreport.com/device/K254174
Methodology: https://510kreport.com/methodology