# K022648: Endovive Initial Placement Direct Pej Kit, Models 6520 & 6521

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Sep 5, 2002 after 27 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- 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 K020120 (2002). 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)
- K020120: Endovive Initial Placement Direct Pej Kit, Endovive Standard Profile Balloon Replacement, Models 6520, 6521, 6220, Boston Scientific Corp (2002)

## Indications for use
The EndoViveTMInitial Placement Direct PEJ Kit is indicated for use for enteral nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated.

Source page: https://510kreport.com/device/K022648
Methodology: https://510kreport.com/methodology