K183400 is an FDA 510(k) clearance for the EnVisio Navigation Sytem, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Elucent Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on March 22, 2019, 105 days after receiving the submission on December 7, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K183400 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 07, 2018 |
| Decision Date | March 22, 2019 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NEU — Marker, Radiographic, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |