# K171347: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

- Pathway: 510(k) (Special)
- Applicant: Xeridiem Medical Devices
- Decided: Jun 6, 2017 after 29 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: 4 generations back to K901501 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142075: BI-Funnel Gastrostomy Feeding Tube, Tri-Funnel Gastrostomy Feeding Tube, Xeridiem (Formerly Mri) (2015) Summary page 6.
- K130611: Entuit Thrive Balloon Retention Gastrostomy Feeding Tube, Xeridiem Medical Devices (2013) Summary page 6.

## Indications for use
The Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit® connector are indicated for placement in adult populations that require enteral feeding, medication administration or gastric decompression through an established gastrointestinal stoma tract. The Entuit® Gastrostomy BR Balloon Retention Feeding Tube with ENFit® Connection is indicated for use in percutaneous placement of an enteral feeding tube in adult and pediatric patients that require enteral feeding, medication administration or decompression through an established gastrointestinal stoma tract.

Source page: https://510kreport.com/device/K171347
Methodology: https://510kreport.com/methodology