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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2016-03-26 under 510(k) 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. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K160129.

When did MRII Cranial Drill and Accessories receive FDA 510(k) clearance?

MRII Cranial Drill and Accessories received FDA 510(k) clearance on 2016-03-26, under 510(k) number K160129.

Who is the listed applicant for MRII Cranial Drill and Accessories?

The FDA 510(k) record lists Mri Interventions, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Mri Interventions, Inc. as applicant

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Related Devices (Code: HBG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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