FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NICO BrainPath
K Number: K172433
·
Decision Sep 7, 2017
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
42
Applicant Total
9
Review Days
27
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Basic Information
- Device Name
- NICO BrainPath
- K Number
- K172433
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.4800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nico Corporation
- Date Received
- August 11, 2017
- Decision Date
- September 7, 2017
- Product Code
- GZT
- 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 |
|---|---|---|---|
| GZT | Retractor, Self-Retaining, For Neurosurgery | FDA class 2 | Neurology |
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Other Clearances by Nico Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K232567 | Myriad SPECTRA Light Source | Mar 14, 2024 | Substantially Equivalent |
| K191599 | NICO Myriad NOVUS | Sep 13, 2019 | Substantially Equivalent |
| K182340 | NICO Myriad | Sep 20, 2018 | Substantially Equivalent |
| K161307 | NICO Myriad | Dec 21, 2016 | Substantially Equivalent |
| K162075 | NICO TRIOwand | Aug 11, 2016 | Substantially Equivalent |
| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook | Jun 12, 2015 | Substantially Equivalent |
| K150993 | NICO TRIOwand | Apr 23, 2015 | Substantially Equivalent |
| K120691 | BRAIN PORT | Jun 5, 2012 | Substantially Equivalent |