# K132436: Varioguide Drill Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Mar 20, 2014 after 227 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- 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 K961113 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122456: Mrii Crainial Drill, Mri Interventions, Inc. (2013) Summary page 1.

## Indications for use
The VarioGuide Drill Kit used in conjunction with BrainLab's VarioGuide is intended for creating an access point in the skull during intracranial procedures. The device is not intended for implant. This device is intended for "single patient use only."

Source page: https://510kreport.com/device/K132436
Methodology: https://510kreport.com/methodology