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Mrii Crainial Drill

by Mri Interventions, Inc.

510(k) K122456

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK122456 Date22 Mar 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HBG
Device Class
Class II
Regulation
21 CFR Part 882.4300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mrii Cranial Drill is a drill used to provide access through the skull for neurological procedures such as ventriculostomy, biopsy, or catheter placement. It is designed for use in or near an MR scanner with a maximum strength of 3T. The device is classified as a drill, burr, trephine, or accessory, and is part of the neurology medical specialty.

The Mrii Cranial Drill is intended for single use and is supplied with accessories. It is regulated under the FDA 510(k) clearance, with a product code of HBG and a regulation number of 882.4300. The device is available in various sizes, as indicated by the registration numbers listed. It should be stored and used according to the manufacturer's instructions, and is designed for use in a clinical setting, such as a hospital or medical facility.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mrii Cranial Drill used for?

    The Mrii Cranial Drill is used to provide access through the skull for neurological procedures such as ventriculostomy, biopsy, or catheter placement.

  • Is the Mrii Cranial Drill suitable for use in an MR scanner?

    Yes, the Mrii Cranial Drill is designed for use in or near an MR scanner with a maximum strength of 3T.

  • Is the Mrii Cranial Drill intended for single or multiple use?

    The Mrii Cranial Drill is intended for single use and is supplied with accessories.

  • How should the Mrii Cranial Drill be stored and used?

    The Mrii Cranial Drill should be stored and used according to the manufacturer's instructions, and is designed for use in a clinical setting, such as a hospital or medical facility.