# K083685: Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285

- Pathway: 510(k) (Traditional)
- Applicant: Mri Manufacturing and Research, Inc.
- Decided: Jun 25, 2009 after 195 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: 2 generations back to K901501 (1990). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962375: Microvasive Balloon Gastrostomy Tube Kit, Boston Scientific Corp (1996) Summary page 1.
- K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P, Boston Scientific Corp (2002) Summary page 1.

## Most influential descendants
- K130674: Entuit Thrive LP Balloon Retention Gastrostomy Feeding Tube (2014), 2 descendants of its own
- K180708: Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX  Low Profile Gastrostomy Feeding Tube, PromaX  LP Patient Care Kit with ENFit (2018), 1 descendant of its own
- K232046: Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection (2023), 0 descendants of its own

## Indications for use
The EndoViveTM Low Profile Replacement Gastrostomy Tube is indicated in adult and pediatric populations 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. The replacement tube may also be used for decompression.

Source page: https://510kreport.com/device/K083685
Methodology: https://510kreport.com/methodology