# K254170: Percutaneous Endoscopic Gastrostomy (PEG) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Degania Silicone, Ltd.
- Decided: Mar 20, 2026 after 87 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: 3 generations back to K920703 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213356: Entuit PEG, Entuit PEGJ, Wilson-Cook Medical, Inc. (2022) Summary page 5.

## Indications for use
The PEG Catheter Kit 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.

Source page: https://510kreport.com/device/K254170
Methodology: https://510kreport.com/methodology