# K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 9, 2002 after 190 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.
16 later devices descend from it; 4 cite it directly.
0 of 17 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) Securi-T Initial Placement Gastrostomy Kit: named in the summary without a submission number
- (no number) Endovive Low Profile Button Replacement Gastrostomy Tube: named in the summary without a submission number
- (no number) Endovive Low Profile Initial Placement Gastrostomy Kit: 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
- K083685: Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 (2009), 3 descendants of its own
- K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit (2003), 3 descendants of its own
- K130674: Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube (2014), 2 descendants of its own
- K083684: Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX (2009), 2 descendants of its own

## Indications for use
The Endovive Initial Placement Gastrostomy Kits (Guidewire & Pull) and the Securi-T Initial Placement Gastrostomy Kits (Guidewire & Pull) are indicated for adult and pediatric populations to provide nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The Endovive Low Profile Button Replacement Gastrostomy Tube is indicated in adult and pediatric populations to provide nutrition directly into the stomach through an existing stoma. They are indicated for use on patients who are unable to consume nutrition by conventional means.

Source page: https://510kreport.com/device/K014297
Methodology: https://510kreport.com/methodology