# K190499: Gem FlowCoupler System

- Pathway: 510(k) (Traditional)
- Applicant: Baxter/ Synovis Micro Companies Alliance, Inc.
- Decided: Sep 6, 2019 after 189 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K093310 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143589: GEM Flow COUPLER Device and System, Synovis Life Technologies, Inc. (2015) Summary page 4.

## Indications for use
The VESSEL EVERTER System is indicated for use with the Microvascular Anastomotic COUPLER and FLOW COUPLER Device in the anastomosis of only arteries normally encountered in microsurgical procedures only in the peripheral vascular system. The VESSEL EVERTER System is indicated for use with COUPLER and FLOW COUPLER System sizes from 2.0 to 4.0 mm.

Source page: https://510kreport.com/device/K190499
Methodology: https://510kreport.com/methodology