# K161003: EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Jun 17, 2016 after 67 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910584 (1991). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910584: One Step Button (TM), Applied Medical Technologies (1991) Summary page 5.
- K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P, Boston Scientific Corp (2002) Summary page 5.
- K920894: Decompression Tubes, Applied Medical Technologies (1992) Summary page 5.

## Most influential descendants
- K191844: Fidmi Low Profile Enteral Feeding Device (2019), 0 descendants of its own

## Recalls of this device
- Dec 19, 2023 · Class II · Z-1153-2024: Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the 

## Indications for use
The One Step Button device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. The EndoVive Low Profile Replacement Button Gastrostomy device is intended to provide nutrition to a patient directly into the stomach through a stoma. It is indicated for use on patients who are unable to consume nutrition by conventional means. The Right Angle Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means. The Bolus Feeding Set is intended to provide nutrition to a patient directly into the stomach through a gastrostomy tube. It is indicated for use on patients who are unable to consume nutrition by conventional means. The Right Angle Decompression Tube is intended to provide stomach decompression through a gastrostomy tube. It is indicated for use on patients who require enteral feeding as a means of nutritional support

Source page: https://510kreport.com/device/K161003
Methodology: https://510kreport.com/methodology