FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Arcus Head Fixation Frame
K Number: K191701
·
Decision Nov 15, 2019
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
49
Applicant Total
14
Review Days
143
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Basic Information
- Device Name
- Arcus Head Fixation Frame
- K Number
- K191701
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4460
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Interventions, Inc.
- Date Received
- June 25, 2019
- Decision Date
- November 15, 2019
- Product Code
- HBL
- 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 |
|---|---|---|---|
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | FDA class 2 | Neurology |
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|---|---|---|---|
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| K181195 | ClearPoint System | Nov 2, 2018 | Substantially Equivalent |
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| 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 |
| K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm | Jul 8, 2015 | Substantially Equivalent |
| K132436 | VARIOGUIDE DRILL KIT | Mar 20, 2014 | Substantially Equivalent |