K150378 is an FDA 510(k) clearance for the NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook. 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 June 12, 2015, 119 days after receiving the submission on February 13, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K150378 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2015 |
| Decision Date | June 12, 2015 |
| Days to Decision | 119 days |
| Submission Type | Traditional |
| 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 |