Disposable Sterile Skull Drill (LZ)— 510(k) K254177
Substantially EquivalentGuizhou Zirui Technology Co., Ltd.
FDA 510(k) clearance K254177 for Disposable Sterile Skull Drill (LZ), Substantially Equivalent on 2026-09-11. Applicant: Guizhou Zirui Technology Co., Ltd.. Device class: 2.
Summary
The Disposable Sterile Skull Drill (LZ) is a single-use cranial drill under HBF, the code for powered compound drills, burrs, and trephines and their accessories. "LZ" is probably a model designation. The record doesn't say.
Class II, 21 CFR 882.4305, Neurology panel, Traditional 510(k).
Guizhou Zirui Technology filed it from Zunyi, China, on December 23, 2025, the same day as its K254174 Surgical Power System. Both cleared on September 11, 2026, 262 days later. The record doesn't link the two.
Clearance details
- Applicant
- Guizhou Zirui Technology Co., Ltd.
- Product code
- Product code HBF
- Device class
- Class 2
- Regulation
- 21 CFR 882.4305
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zunyi, CN
Recent devices under product code HBF
view allMore clearances from Guizhou Zirui Technology Co., Ltd.
view allAdverse events under product code HBF
product code HBF- Injury
- 587
- Malfunction
- 621
- Other
- 1
- Total
- 1,209
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.