Surgical Power System— 510(k) K254174
Substantially EquivalentGuizhou Zirui Technology Co., Ltd.
FDA 510(k) clearance K254174 for Surgical Power System, Substantially Equivalent on 2026-09-11. Applicant: Guizhou Zirui Technology Co., Ltd.. Device class: 2.
Summary
The Surgical Power System is an electric surgical drill motor, product code HBC. The name is generic and the record doesn't add much.
Class II, 21 CFR 882.4360. The Neurology panel reviewed it as a Traditional 510(k).
Guizhou Zirui Technology filed from Zunyi, China, on December 23, 2025. The same company filed K254177, a disposable skull drill, that day, and both cleared on September 11, 2026 after 262 days. The record doesn't say whether the two are used together.
Clearance details
- Applicant
- Guizhou Zirui Technology Co., Ltd.
- Product code
- Product code HBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.4360
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zunyi, CN
Recent devices under product code HBC
view allMore clearances from Guizhou Zirui Technology Co., Ltd.
view allAdverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.