# K142793: AbbVie PEG

- Pathway: 510(k) (Traditional)
- Applicant: AbbVie, Inc.
- Decided: Jan 14, 2015 after 110 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K014297 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133087: Abbvie Peg, AbbVie, Inc. (2014) Summary page 4.

## Recalls of this device
- Apr 27, 2017 · Class II · Z-2178-2017: PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
- Apr 27, 2017 · Class II · Z-2176-2017: 
- Apr 27, 2017 · Class II · Z-2177-2017: PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.
- Nov 22, 2016 · Class II · Z-0786-2017: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

## Indications for use
The AbbVie PEG is intended to provide long-term enteral access for administration of medication to the small intestine when used in conjunction with the AbbVie J, intestinal tube. As needed, enteral nutrition may be administered directly to the stomach in parallel with medication delivery to the intestine. The AbbVie PEG is indicated for the administration of the medication DUOPA (carbidopa and levodopa enteral suspension).

Source page: https://510kreport.com/device/K142793
Methodology: https://510kreport.com/methodology