FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
BrightMatter Guide with Surface Trace Registration
K Number: K153281
·
Decision Mar 30, 2016
Classifications
1
FEI Numbers
250
Registration Numbers
250
Same Product Code
422
Applicant Total
10
Review Days
139
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Basic Information
- Device Name
- BrightMatter Guide with Surface Trace Registration
- K Number
- K153281
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Synaptive Medical, Inc.
- Date Received
- November 12, 2015
- Decision Date
- March 30, 2016
- 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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|---|---|---|---|
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| K200327 | Evry | Apr 29, 2020 | Substantially Equivalent |
| K183325 | Modus Nav | Jul 14, 2019 | Substantially Equivalent |
| K180394 | BrightMatter Plan 1.6.0 | Mar 9, 2018 | Substantially Equivalent |
| K160523 | BrightMatter Guide with BrightMatter Pointer | Jun 24, 2016 | Substantially Equivalent |
| K153284 | Synaptive ImageDrive Pro | Mar 29, 2016 | Substantially Equivalent |
| K142024 | BRIGHTMATTER NAVIGATION SYSTEM | Apr 2, 2015 | Substantially Equivalent |
| K140337 | BRIGHTMATTER PLANNING SOFTWARE | Jun 2, 2014 | Substantially Equivalent |