# K132727: Gem Flow Coupler Device and System

- Pathway: 510(k) (Special)
- Applicant: Synovis Life Technologies, Inc.
- Decided: Oct 22, 2013 after 49 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093310 (2010). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093310: Gem Flow Coupler Device and System, Synovis Micro Companies Alliance, Inc. (2010)

## Most influential descendants
- K142309: GEM Flow COUPLER Device and System (2014), 3 descendants of its own
- K143589: GEM Flow COUPLER Device and System (2015), 2 descendants of its own
- K233394: Gem Flow Now (GEM2770-FN) (2024), 0 descendants of its own
- K190499: Gem FlowCoupler System (2019), 0 descendants of its own

## Recalls of this device
- Apr 21, 2016 · Class II · Z-1627-2016: Instructions for use booklet may puncture the outer Tyvek lid.
- Apr 21, 2016 · Class II · Z-1629-2016: Instructions for use booklet may puncture the outer Tyvek lid.
- Apr 21, 2016 · Class II · Z-1630-2016: Instructions for use booklet may puncture the outer Tyvek lid.
- Apr 21, 2016 · Class II · Z-1628-2016: Instructions for use booklet may puncture the outer Tyvek lid.
- Jul 11, 2014 · Class II · Z-2126-2014: Baxter Healthcare is recalling the FlowCOUPLER Device because there is a possibility that some units may not maintain electrical continuity during handling intra-operatively and post-operatively, resu

## Indications for use
The FlowCOUPLER Device is a single use, implantable device that is intended to be used in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and vascular reconstructive procedures. The FlowCOUPLER Device includes a pair of permanently implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit onto one of the rings. When the FlowCOUPLER Device is used in conjunction with the FlowCOUPLER Monitor, the FlowCOUPLER System is intended to detect blood flow and confirm vessel patency intra-operatively and post-operatively at the anastomotic site. Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The FlowCOUPLER Doppler probe is not intended to be a permanent implant and should be removed 3 to 14 days post-operatively.

Source page: https://510kreport.com/device/K132727
Methodology: https://510kreport.com/methodology