# K150679: EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: May 29, 2015 after 73 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K014297 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit, Boston Scientific Corp (2003) Summary page 5.

## Recalls of this device
- Feb 10, 2026 · Class II · Z-1551-2026: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic so
- Feb 20, 2024 · Class II · Z-1514-2024: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leadi
- Feb 20, 2024 · Class II · Z-1513-2024: Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leadi

## Indications for use
The Initial Placement PEG is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means.

Source page: https://510kreport.com/device/K150679
Methodology: https://510kreport.com/methodology