# K093310: Gem Flow Coupler Device and System

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Micro Companies Alliance, Inc.
- Decided: Feb 1, 2010 after 102 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132727: Gem Flow Coupler Device and System (2013), 4 descendants of its own
- 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
- K191252: Gem FlowCoupler System (2019), 1 descendant of its own
- K233394: Gem Flow Now (GEM2770-FN) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K093310
Methodology: https://510kreport.com/methodology