# K033778: Modification to Bard Aquaguide Ureteral Conduit

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 30, 2003 after 26 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 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® AquaGuide™ Ureteral Conduit: named in the summary without a submission number

## Most influential descendants
- K043418: Cook Pediatric Flexor Ureteral Access Shealth (2005), 4 descendants of its own
- K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (2017), 2 descendants of its own
- K250132: Ureteral Access Sheath (2025), 0 descendants of its own
- K182403: Peel-Away Introducer (2019), 0 descendants of its own
- K072521: Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath (2007), 0 descendants of its own

## Indications for use
The Bard® AquaGuideTM Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.

Source page: https://510kreport.com/device/K033778
Methodology: https://510kreport.com/methodology