# K020120: Endovive Initial Placement Direct Pej Kit, Endovive Standard Profile Balloon Replacement, Models 6520, 6521, 6220

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 2, 2002 after 200 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
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Endovive Initial Placement Gastrostomy Kit: named in the summary without a submission number
- (no number) Endovive Balloon Replacement Gastrostomy Tube: named in the summary without a submission number
- (no number) Endovive Percutaneous Endoscopic Jejunostomy Device: named in the summary without a submission number

## Most influential descendants
- K030855: Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit (2003), 6 descendants of its own
- K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit (2003), 3 descendants of its own
- K133087: Abbvie Peg (2014), 1 descendant of its own
- K061021: Entake Standard and Safety Peg System (2006), 1 descendant of its own
- K182248: Aspire Venting Tube (2018), 0 descendants of its own

## Indications for use
The Endovive Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The Endovive Standard Profile Balloon Replacement Tube is indicated for use in percutaneous placement of an enteral feeding tube for feeding and/or administration of medication in conjunction with an established GI stoma tract. Typical uses include the replacement of existing gastrostomy and/or jejunostomy feeding tubes. The Standard Profile Balloon Replacement Tube may also be used for decompression.

Source page: https://510kreport.com/device/K020120
Methodology: https://510kreport.com/methodology