# K143589: GEM Flow COUPLER Device and System

- Pathway: 510(k) (Special)
- Applicant: Synovis Life Technologies, Inc.
- Decided: Jan 16, 2015 after 29 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K093310 (2010). 3 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K142309: GEM Flow COUPLER Device and System, Synovis Life Technologies, Inc. (2014). Our reading of the summary gave K142609, FDA’s number for CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (Guangzhou Wondfo Biotech Co., Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “GEM Flow COUPLER Device and System”.

## Most influential descendants
- 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-1631-2016: 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.

## Indications for use
The Flow COUPLER 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 Flow COUPLER 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 Flow COUPLER Device is used in conjunction with the Flow COUPLER Monitor, the Flow COUPLER 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 Flow COUPLER 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/K143589
Methodology: https://510kreport.com/methodology