510(k) clearance

Disposable Sterile Skull Drill (LZ)

FDA 510(k) source

510(k) number

K254177

Applicant

Guizhou Zirui Technology Co., Ltd.

Decision date

Sep 11, 2026

Date received

Dec 23, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

HBF

Device type

Drills, Burrs, Trephines & Accessories (Compound, Powered)

Device class

Class II

Regulation

21 CFR 882.4305

Advisory committee

Neurology

Statement or summary

Summary

Third party

N

Location

Zunyi, CN