Surgical Power System

FDA 510(k) K254174 · Guizhou Zirui Technology Co., Ltd.

Substantially Equivalent

510(k) numberK254174

Submission

Device name
Surgical Power System
Applicant
Guizhou Zirui Technology Co., Ltd.
Zunyi, CN
Received
December 23, 2025
Decision date
September 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBC – Motor, Drill, Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4360
Specialty
Neurology

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Questions and answers

When was Surgical Power System cleared by the FDA?

Surgical Power System (K254174) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 262 days after the submission was received.

What is the product code of K254174?

The FDA product code is HBC – Motor, Drill, Electric, a Class II (moderate risk) device regulated under 21 CFR 882.4360.