FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRII CRAINIAL DRILL
K Number: K122456
·
Decision Mar 22, 2013
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
16
Applicant Total
14
Review Days
221
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Basic Information
- Device Name
- MRII CRAINIAL DRILL
- K Number
- K122456
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4300
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Interventions, Inc.
- Date Received
- August 13, 2012
- Decision Date
- March 22, 2013
- 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 |
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