BRIGHTMATTER NAVIGATION SYSTEM
FDA 510(k) clearance K142024 · decided 2015-04-02
Clearance details
- K-number
- K142024
- Device name
- BRIGHTMATTER NAVIGATION SYSTEM
- Applicant
- Synaptive Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-07-25
- Decision date
- 2015-04-02
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synaptive Medical BrightMatter Navigator System (Guide System). Part number SYN-0026. The recall (Z-0480-2016) | Synaptive Medical, Inc. | 2015-12-23 |