# K231403: evoDrill Cranial Perforator

- Pathway: 510(k) (Traditional)
- Applicant: Evonos GmbH & Co. KG
- Decided: Mar 6, 2024 after 296 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: 2 generations back to K791101 (1979). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892866: Automatic Cranial Drill (Perforator), Acra Cut, Inc. (1989) Summary page 5.
- K933894: Disposable Perforator, Codman & Shurtleff, Inc. (1993) Summary page 5.

## Most influential descendants
- K254174: Surgical Power System (2026), 0 descendants of its own
- K254177: Disposable Sterile Skull Drill (LZ) (2026), 0 descendants of its own

## Indications for use
The evoDrill Cranial Perforators are single-use surgical devices for cranium perforation. The perforators with the 3mm step automatically release and stop perforating at cranial bone thickness of at least 3mm. The perforators with the 1mm step automatically release and stop perforating at cranial bone thickness of at least 1mm.

Source page: https://510kreport.com/device/K231403
Methodology: https://510kreport.com/methodology