The following data is part of a premarket notification filed by Fortimedix Surgical B.v. with the FDA for Fmx314 Surgical Platform.
| Device ID | K160797 |
| 510k Number | K160797 |
| Device Name: | FMX314 Surgical Platform |
| Classification | Laparoscopic Single Port Access Device |
| Applicant | Fortimedix Surgical B.V. Daelderweg 20 Nuth, NL 6361 Hk |
| Contact | Dirkjan Bakker |
| Correspondent | Richard A. Vincins EMERGO GLOBAL CONSULTING, LLC 816 CONGRESS AVENUE SUITE 1400 Austin, TX 78701 |
| Product Code | OTJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-08-26 |
| Summary: | summary |