K120691 is an FDA 510(k) clearance for the BRAIN PORT. 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 5, 2012, 90 days after receiving the submission on March 7, 2012.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4800.
| 510(k) Number | K120691 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2012 |
| Decision Date | June 05, 2012 |
| Days to Decision | 90 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 |