Mrii Crainial Drill
FDA 510(k) K122456 · Mri Interventions, Inc.
510(k) numberK122456
Submission
- Device name
- Mrii Crainial Drill
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- August 13, 2012
- Decision date
- March 22, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K160129 | MRII Cranial Drill and AccessoriesHBG · Special | 03/26/2016SE |
| K160434 | ClearPoint SystemHAW · Special | 03/17/2016SE |
| K142505 | ClearPoint SystemHAW · Traditional | 10/21/2015SE |
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Questions and answers
When was Mrii Crainial Drill cleared by the FDA?
Mrii Crainial Drill (K122456) received a 510(k) decision of Substantially Equivalent on March 22, 2013, 221 days after the submission was received.
What is the product code of K122456?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.