# K213356: Entuit PEG, Entuit PEGJ

- Pathway: 510(k) (Special)
- Applicant: Wilson-Cook Medical, Inc.
- Decided: Jan 20, 2022 after 100 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: 2 generations back to K920703 (1993). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183336: Entuit PEG, Entuit PEGJ, Wilson-Cook Medical, Inc. (2019) Summary page 5.

## Most influential descendants
- K254170: Percutaneous Endoscopic Gastrostomy (PEG) Kit (2026), 0 descendants of its own

## Indications for use
The Entuit PEG is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only. The Entuit PEGIJ is intended for percutaneous endoscopic placement to provide enteral nutrition and/or medication to patients requiring nutritional support, and gastric decompression. This device is indicated for adult use only.

Source page: https://510kreport.com/device/K213356
Methodology: https://510kreport.com/methodology