FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K Number: K151536
·
Decision Jul 8, 2015
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
14
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
- K Number
- K151536
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Interventions, Inc.
- Date Received
- June 8, 2015
- Decision Date
- July 8, 2015
- Product Code
- HBG
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HBG), ordered by most recent decision date.
LEGACY
FDA 510(k)
FDA Class 2
·Neurology
Taps for Resorbable Screws
FDA 510(k)
FDA Class 2
·Neurology
SpineGuard DSG Zavation Screw System
FDA 510(k)
FDA Class 2
·Neurology
MRII Cranial Drill and Accessories
FDA 510(k)
FDA Class 2
·Neurology
MRII CRAINIAL DRILL
FDA 510(k)
FDA Class 2
·Neurology
HAND DRILL, MODEL 11-9901-7
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Mri Interventions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200079 | ClearPoint System and Accessories | Feb 13, 2020 | Substantially Equivalent |
| K191701 | Arcus Head Fixation Frame | Nov 15, 2019 | Substantially Equivalent |
| K191400 | Voyager Trajectory Array Guide (V-TAG) | Jun 21, 2019 | Substantially Equivalent |
| K181731 | MR Compatible Aspiration Kit | Nov 20, 2018 | Substantially Equivalent |
| K181195 | ClearPoint System | Nov 2, 2018 | Substantially Equivalent |
| K171257 | ClearPoint System | Oct 20, 2017 | Substantially Equivalent |
| K160129 | MRII Cranial Drill and Accessories | Mar 26, 2016 | Substantially Equivalent |
| K160434 | ClearPoint System | Mar 17, 2016 | Substantially Equivalent |
| K142505 | ClearPoint System | Oct 21, 2015 | Substantially Equivalent |
| K132436 | VARIOGUIDE DRILL KIT | Mar 20, 2014 | Substantially Equivalent |