# K160797: FMX314 Surgical Platform

- Pathway: 510(k) (Traditional)
- Applicant: Fortimedix Surgical B.V.
- Decided: Aug 26, 2016 after 156 days
- Product code: OTJ (Laparoscopic Single Port Access Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940232 (1994). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090902: Spider Single Port Surgical Device, Support Arm Accessory,  Model 90001, 90002, 90003, Transenterix, Inc. (2009) Summary page 5.
- K091697: Spider Surgical Instruments, Models 90004, 90005, 90007, 90009, 90010, 90012, 90013, 90015, Transenterix, Inc. (2009) Summary page 5.

## Indications for use
The FMX314 Surgical Platform is composed of FMX314 Introducer and FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery: - The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments. - The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, retracting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

Source page: https://510kreport.com/device/K160797
Methodology: https://510kreport.com/methodology