# K201741: Gabriel 3 Way EnFit Valve

- Pathway: 510(k) (Traditional)
- Applicant: Syncro Medical Innovations, Inc.
- Decided: Nov 5, 2020 after 133 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915171 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915171: Lopez Valve TM  II, Icu Medical, Inc. (1992) Summary page 4.

## Indications for use
The Gabriel 3-way EnFit valve is a three-way closed system valve with three ports for control of fluid flow (nutrition, medication and water) between devices with EnFit connectors and catheter tip syringe. It can be used in pediatric, adult and elderly patients, for up to 7 days.

Source page: https://510kreport.com/device/K201741
Methodology: https://510kreport.com/methodology