# K061021: Entake Standard and Safety Peg System

- Pathway: 510(k) (Traditional)
- Applicant: Conmedcorp
- Decided: Apr 28, 2006 after 15 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 28 (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). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K924065: Mic Peg Tube, Medical Innovations Corp. (1994) Summary page 1.
- K031538: Endovive Initial Placement Peg Kit, Direct Pej Kit, and Peg Safety Kit, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K182248: Aspire Venting Tube (2018), 0 descendants of its own

## Recalls of this device
- Dec 4, 2008 · Not classified · Z-2187-2009: The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal
- Dec 4, 2008 · Not classified · Z-2186-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2200-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2203-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2183-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2185-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2184-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2205-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2191-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2193-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2194-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2204-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2197-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2206-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2192-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2189-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2181-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2198-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2195-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2180-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2196-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2188-2009: The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal
- Dec 4, 2008 · Not classified · Z-2201-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2207-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2199-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2190-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2182-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 
- Dec 4, 2008 · Not classified · Z-2202-2009: Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into 

## Indications for use
For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

Source page: https://510kreport.com/device/K061021
Methodology: https://510kreport.com/methodology
