ClearPoint System
FDA 510(k) clearance K181195 · decided 2018-11-02
Clearance details
- K-number
- K181195
- Device name
- ClearPoint System
- Applicant
- Mri Interventions, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-05-04
- Decision date
- 2018-11-02
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- ORR
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ClearPoint System (K171257) | Mri Interventions, Inc. | 2017-10-20 |
| SURGIVISION INC. CLEARPOINT SYSTEM (K111073) | Surgi-Vision, Inc. | 2011-06-22 |
| CLEARPOINT SYSTEM (K100836) | Surgivision, Inc. | 2010-06-16 |
Recalls involving this device
No recalls on record reference this clearance.