# MVR: Device, Anastomotic, Microvascular

- Device class: 2; regulation: 21 CFR 878.4300; FDA's rule: 510(k) required
- FDA decisions: 9
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1986: 1
- 2004: 1
- 2009: 1
- 2010: 1
- 2013: 1
- 2014: 1
- 2015: 1
- 2019: 2

## Most-cited predicates
- K093310: Gem Flow Coupler Device and System (2010), cited by 3
- K143589: GEM Flow COUPLER Device and System (2015), cited by 2
- K132727: Gem Flow Coupler Device and System (2013), cited by 1
- K861985: 3M Brand Microvascular Anastomotic Coupler (27XX) (1986), cited by 1
- K142309: GEM Flow COUPLER Device and System (2014), cited by 1
- K191252: Gem FlowCoupler System (2019), cited by 1
- K040163: Microvascular Anastomotic Device (2004), cited by 1

Source page: https://510kreport.com/product-code/MVR
Data by year (CSV): https://510kreport.com/product-code/MVR.csv