K132264 is an FDA 510(k) clearance for the PRIMADO2 TOTAL SURGICAL SYSTEM. This device is classified as a Motor, Drill, Electric (Class II - Special Controls, product code HBC).
Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on December 17, 2013, 148 days after receiving the submission on July 22, 2013.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4360.
| 510(k) Number | K132264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2013 |
| Decision Date | December 17, 2013 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HBC — Motor, Drill, Electric |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.4360 |