Skip to content

FMX314 Surgical Platform

by Fortimedix Surgical B.V. 510(k)

Active United States

510(k) K160797

Overview

The FMX314 Surgical Platform is a laparoscopic single port access device designed to enable multi-instrument access through a single 15mm trocar. It consists of a reusable introducer, a single-use hub cap and sealing unit, and six disposable articulating instruments including a grasper, Maryland, clip applier, scissors, hook-knife, and suction/irrigation device. The system is indicated for use in gastroenterology and urology procedures.

The device is supplied with reusable and single-use components and is intended for single-patient use. It is stored at room temperature and is not evaluated for MRI safety. The FMX314 Surgical Platform is authorized under FDA 510(k) clearance with K-number K160797 and is classified under product code OTJ.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160797 Date26 Aug 2016ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
OTJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Questions

  • What procedures is the FMX314 Surgical Platform indicated for?

    The FMX314 Surgical Platform is indicated for use in gastroenterology and urology procedures. It is designed to support laparoscopic single port access, allowing multiple instruments to be used through a single entry point, which may reduce tissue trauma and improve surgical efficiency in these specialties.

  • How is the FMX314 Surgical Platform supplied?

    The system is supplied with both reusable and single-use components. It includes a reusable introducer, a single-use hub cap and sealing unit, and six disposable articulating instruments. This combination supports functionality while maintaining hygiene standards for single-patient use.

  • Is the FMX314 Surgical Platform sterile?

    The device data does not explicitly state whether the FMX314 Surgical Platform is supplied sterile. However, given that it includes single-use components and is intended for surgical use, it is likely sterilized prior to use. Users should refer to the manufacturer’s labeling for specific sterility information.

  • Can the FMX314 Surgical Platform be reused?

    The FMX314 Surgical Platform is intended for single-patient use. While it includes a reusable introducer, the hub cap, sealing unit, and all six articulating instruments are disposable and not designed for reuse. This design helps ensure patient safety and consistent performance.

  • What sizes and models are available for the FMX314 Surgical Platform?

    The FMX314 Surgical Platform is designed to function through a single 15mm trocar, indicating a standardized size for port access. The device data does not list alternative models or sizes, suggesting that this specific configuration is intended for the described clinical applications.