# K972025: Radius Pull Percutaneous Endoscopic Gastrostomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Radius Intl., Inc.
- Decided: Jan 23, 1998 after 235 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 29 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bard Ponsky-Gauderer Silicone Peg Tray: named in the summary without a submission number

## Most influential descendants
- K033562: Fastrac Gastric Access Port Kit (2003), 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-2179-2009: 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-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
The device is indicated for percutaneous placement of a long term initial feeding and/or decompression gastrostomy device.

Source page: https://510kreport.com/device/K972025
Methodology: https://510kreport.com/methodology