# K861985: 3M Brand Microvascular Anastomotic Coupler (27XX)

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Dec 4, 1986 after 196 days
- Product code: MVR (Device, Anastomotic, Microvascular)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K040163: Microvascular Anastomotic Device (2004), 1 descendant of its own
- K090679: Vesselink Microvascular Anastomotic Coupler System (2009), 0 descendants of its own

## Recalls of this device
- Mar 5, 2020 · Class II · Z-1685-2020: The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
- Mar 5, 2020 · Class II · Z-1687-2020: The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device
- Mar 5, 2020 · Class II · Z-1686-2020: The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

Source page: https://510kreport.com/device/K861985
Methodology: https://510kreport.com/methodology