K160797 is an FDA 510(k) clearance for the FMX314 Surgical Platform, a Laparoscopic Single Port Access Device (Class II — Special Controls, product code OTJ), submitted by Fortimedix Surgical B.V. (Nuth, NL). The FDA issued a Cleared decision on August 26, 2016, 156 days after receiving the submission on March 23, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K160797 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 23, 2016 |
| Decision Date | August 26, 2016 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OTJ — Laparoscopic Single Port Access Device |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | A Multiple Instrument And/or Camera Port During Minimally Invasive Abdominal Laparoscopic Surgery. |