# K151536: SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

- Pathway: 510(k) (Special)
- Applicant: Mri Interventions, Inc.
- Decided: Jul 8, 2015 after 30 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: 2 generations back to K961113 (1996). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 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 5.

## Most influential descendants
- K160129: MRII Cranial Drill and Accessories (2016), 1 descendant of its own
- K170442: Cranial Drill Bits and Accessories (2017), 0 descendants of its own

## Indications for use
The SmartTwist™ MRII Hand Drill and accessories are 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 strength. The SmartTwist MRII Hand Drill and accessories are intended to be used only when the scanner is not performing a scan. The SmartTwist MRII Hand Drill is intended for single use only.

Source page: https://510kreport.com/device/K151536
Methodology: https://510kreport.com/methodology