# K254177: Disposable Sterile Skull Drill (LZ)

- Pathway: 510(k) (Traditional)
- Applicant: Guizhou Zirui Technology Co., Ltd.
- Decided: Sep 11, 2026 after 262 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K791101 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231403: evoDrill Cranial Perforator, Evonos GmbH & Co. KG (2024) Summary page 6.

## Indications for use
Disposable Sterile Skull Drill is a sterile, single-use device intended for cranium perforation during neurosurgical procedures to establish surgical access.

Source page: https://510kreport.com/device/K254177
Methodology: https://510kreport.com/methodology