MRII Cranial Drill and Accessories
FDA 510(k) K160129 · Mri Interventions, Inc.
510(k) numberK160129
Submission
- Device name
- MRII Cranial Drill and Accessories
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- January 20, 2016
- Decision date
- March 26, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | Mri Interventions, Inc. | 07/08/2015SE |
| K122456 | Mrii Crainial DrillHBG · Traditional | Mri Interventions, Inc. | 03/22/2013SE |
| K022712 | Hand Drill, Model 11-9901-7HBG · Traditional | Medical Design, LLC | 11/12/2002SE |
| K022370 | Framelock; Framelock AccessoriesHBG · Traditional | Medtronic Xomed, Inc. | 10/18/2002SE |
| K961113 | CNS Interchangeable Bit Cranial DrillHBG · Traditional | Clinical Neuro Systems, LLC | 06/05/1996SE |
| K932402 | Modification to Ghajar Guide Twist DrillHBG · Traditional | Neurodynamics, Inc. | 08/05/1993SE |
| K915546 | PS Medical Ventriculostomy KitHBG · Traditional | Pudenz-Schulte Medical Research Corp. | 12/30/1991SE |
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| K191400 | Voyager Trajectory Array Guide (V-TAG)HAW · Special | 06/21/2019SE |
| K181731 | MR Compatible Aspiration KitGWG · Traditional | 11/20/2018SE |
| K181195 | ClearPoint SystemORR · Traditional | 11/02/2018SE |
| K171257 | ClearPoint SystemORR · Traditional | 10/20/2017SE |
| K160434 | ClearPoint SystemHAW · Special | 03/17/2016SE |
| K142505 | ClearPoint SystemHAW · Traditional | 10/21/2015SE |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special | 07/08/2015SE |
| K132436 | Varioguide Drill KitHBE · Traditional | 03/20/2014SE |
Questions and answers
When was MRII Cranial Drill and Accessories cleared by the FDA?
MRII Cranial Drill and Accessories (K160129) received a 510(k) decision of Substantially Equivalent on March 26, 2016, 66 days after the submission was received.
What is the product code of K160129?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.