MRII Cranial Drill and Accessories
K-Number: K160129 · 2016-03-26
ApplicantMri Interventions, Inc.
Decision Date2016-03-26
Product CodeHBG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
MRII Cranial Drill and Accessories is a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2016-03-26 under approval number K160129. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MRII Cranial Drill and Accessories?
MRII Cranial Drill and Accessories is a medical device that received FDA 510(k) clearance on 2016-03-26. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K160129.
When was MRII Cranial Drill and Accessories approved by the FDA?
MRII Cranial Drill and Accessories received FDA 510(k) clearance on 2016-03-26, under approval number K160129.
What company makes MRII Cranial Drill and Accessories?
MRII Cranial Drill and Accessories is manufactured by Mri Interventions, Inc..
What is the FDA product code for MRII Cranial Drill and Accessories?
The FDA product code for MRII Cranial Drill and Accessories is HBG.
Other Devices by Mri Interventions, Inc.
Related Devices (Code: HBG)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.