K172433 is an FDA 510(k) clearance for the NICO BrainPath. This device is classified as a Retractor, Self-retaining, For Neurosurgery (Class II - Special Controls, product code GZT).
Submitted by Nico Corporation (Indianapolis, US). The FDA issued a Cleared decision on September 7, 2017, 27 days after receiving the submission on August 11, 2017.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K172433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2017 |
| Decision Date | September 07, 2017 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZT - Retractor, Self-retaining, For Neurosurgery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4800 |