# K962375: Microvasive Balloon Gastrostomy Tube Kit

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Sep 4, 1996 after 76 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 K901501 (1990). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951489: Mri's All Silicone Gastrostomy Tube, Manufacturing & Research, Inc. (1995) Summary page 3.
- K901501: Corpak Gastrostomy Tube, Corpak Co. (1990) Summary page 3.

## Most influential descendants
- K083685: Endovive Low Profile Replacement Gastrostomy Tube, Model 82XX, 8283, 8284, 8285 (2009), 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
- 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
- K130611: Entuit Thrive Balloon Retention Gastrostomy Feeding Tube (2013), 1 descendant of its own

## Indications for use
The Balloon Gastrostomy Tube Kit is indicated for use in percutaneous placement of a gastrostomy tube for feeding and/or medication in conjunction with an established gastrostomy tract, or using a Stamm Procedure. The gastrostomy tube may also be used for gastric decompression

Source page: https://510kreport.com/device/K962375
Methodology: https://510kreport.com/methodology