# K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Jun 27, 2003 after 42 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K014297 (2002). 3 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K030855: Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K061021: Entake Standard and Safety Peg System (2006), 1 descendant of its own
- K182248: Aspire Venting Tube (2018), 0 descendants of its own
- K150679: EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector (2015), 0 descendants of its own

## Recalls of this device
- Feb 20, 2024 · Class II · Z-1516-2024: 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-1515-2024: 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-1517-2024: 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
- May 5, 2009 · Not classified · Z-1631-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1625-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1632-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1626-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1630-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1627-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1629-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- May 5, 2009 · Not classified · Z-1628-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Dec 30, 2008 · Not classified · Z-0912-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Dec 30, 2008 · Not classified · Z-0913-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Dec 30, 2008 · Not classified · Z-0914-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Dec 30, 2008 · Not classified · Z-0911-2009: The user may be unable to pass the device over the guidewire for placement in the patient, resulting in an inability to use the device.
- Jun 2, 2005 · Not classified · Z-0963-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0966-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0968-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0965-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0964-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.
- Jun 2, 2005 · Not classified · Z-0967-05: Two blades may be heat staked onto the stiletto instead of the expected one blade.

## Indications for use
EndoVive Initial Placement PEG Kit is indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. The EndoVive Initial Placement Direct PEJ Kit is indicated for nutritional support and decompression directly into the jejunum when feeding via the upper gastrointestinal tract is contraindicated. The EndoVive Initial Placement PEG Safety Kit is indicated for providing nutrition directly into the stomach in patients who are unable to consume nutrition by conventional means. The safety components of the kit are designed to reduce the potential for inadvertent sharps injury to medical personnel during and after the procedure.

Source page: https://510kreport.com/device/K031538
Methodology: https://510kreport.com/methodology