# K030855: Modification to Endovive Initial Placement Peg Kit, Direct Pej Kit, Peg Safety Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 17, 2003 after 30 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K014297 (2002). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014297: Endovive Initial Placement Gastrostomy Kit; Endovive Low Profile Button Replacement Gastrostomy Tube; Securi-T Initial P, Boston Scientific Corp (2002)
- K020120: Endovive Initial Placement Direct Pej Kit, Endovive Standard Profile Balloon Replacement, Models 6520, 6521, 6220, Boston Scientific Corp (2002)

## Most influential descendants
- K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit (2003), 3 descendants of its own
- K133087: Abbvie Peg (2014), 1 descendant of its own
- 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
- Jun 17, 2008 · Not classified · Z-2236-2008: Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG
- Jun 17, 2008 · Not classified · Z-2237-2008: Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

## Indications for use
EndoViveTMInitial 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 EndoViveTMInitial 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 EndoViveThlInitial 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 tfie procedure.

Source page: https://510kreport.com/device/K030855
Methodology: https://510kreport.com/methodology