FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ClearPoint System and Accessories
K Number: K200079
·
Decision Feb 13, 2020
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
14
Review Days
30
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Basic Information
- Device Name
- ClearPoint System and Accessories
- K Number
- K200079
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mri Interventions, Inc.
- Date Received
- January 14, 2020
- Decision Date
- February 13, 2020
- Product Code
- HAW
- 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 |
|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | FDA class 2 | Neurology |
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Other Clearances by Mri Interventions, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |