# K083684: Endo Vive Standard Replacement Gastrostomy Tube, Model 82XX

- Pathway: 510(k) (Traditional)
- Applicant: Manufacturing & Research, Inc.
- Decided: Feb 5, 2009 after 55 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.
2 later devices descend from it; 1 cites it directly.
0 of 7 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
- K130611: Entuit Thrive Balloon Retention Gastrostomy Feeding Tube (2013), 1 descendant of its own
- K171347: Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection (2017), 0 descendants of its own

## Indications for use
The EndoViveTM Standard 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. Typical uses include the replacement of existing gastrostomy feeding tubes. In addition, the 20F tube is also used for the replacement of initial placement jejunostromy feeding tubes. The replacement tube may also be used for decompression. Note: Only the 20F tube is indicated for jejunal replacement.

Source page: https://510kreport.com/device/K083684
Methodology: https://510kreport.com/methodology