# K915841: Bard Gauderer Universal Percutaneous Endoscopic

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jun 25, 1993 after 549 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K063118: Bard Balloon Dilation Kit with Trifunnel Gastrostomy Tube (2007), 3 descendants of its own
- K092049: Iyunni 3ID Tri-Funnel Gastrostomy Tube Kit (2009), 2 descendants of its own
- K102572: Iyunni 3ID Suprapubic Cystostomy Tube Kit (2010), 0 descendants of its own
- K100173: Iyunni 3ID Tri-Funnel Feeding Tube Kit (2010), 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 

Source page: https://510kreport.com/device/K915841
Methodology: https://510kreport.com/methodology