# K122456: Mrii Crainial Drill

- Pathway: 510(k) (Traditional)
- Applicant: Mri Interventions, Inc.
- Decided: Mar 22, 2013 after 221 days
- Product code: HBG (Drills, Burrs, Trephines & Accessories (Manual))
- Device class: 2
- Regulation: 21 CFR 882.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961113 (1996). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961113: CNS Interchangeable Bit Cranial Drill, Clinical Neuro Systems, LLC (1996) Summary page 1.

## Most influential descendants
- K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (2015), 2 descendants of its own
- K160129: MRII Cranial Drill and Accessories (2016), 1 descendant of its own
- K170442: Cranial Drill Bits and Accessories (2017), 0 descendants of its own
- K132436: Varioguide Drill Kit (2014), 0 descendants of its own

## Indications for use
The MRII Cranial Drill and accessories is intended to provide access through the skull for ventriculostomy or other neurological procedures, such as biopsy or catheter placement, in or near an MR scanner of 3T maximum field strength. The MRI Cranial Drill and accessories are intended to be used only when the scanner is not performing a scan. The MRII Cranial Drill is intended for single use only.

Source page: https://510kreport.com/device/K122456
Methodology: https://510kreport.com/methodology