510(k) · Cleared
ClearedModification to Bard Aquaguide Ureteral Conduit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Dec 30, 2003 after a 26-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Dec 30, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK033778 Modification to Bard Aquaguide Ureteral ConduitC.R. Bard, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK043418 Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
- Descendant · 3 generations on · 0 of its ownK250132 Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
- Descendant · 2 generations on · 0 of its ownK072521 Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · cites it directly4descendants
- K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated · 2017 · 2 generations on2descendants
- K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025 · 3 generations on0descendants
- K182403Peel-Away IntroducerCook Incorporated · 2019 · 3 generations on0descendants
- K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033778 | Modification to Bard Aquaguide Ureteral Conduit | C.R. Bard, Inc. | 2003 | — |
| +1 | K043418 | Cook Pediatric Flexor Ureteral Access Shealth | Cook Urological, Inc. | 2005 | 1 |
| +2 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral… | Cook Incorporated | 2017 | — |
| +3 | K250132 | Ureteral Access Sheath | Zhejiang YiGao Medical Technology Co., Ltd. | 2025 | — |
| +3 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
| +2 | K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath | Cook Urological, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FED? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bard® AquaGuide™ Ureteral Conduit Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043418 | Cook Pediatric Flexor Ureteral Access Shealth | 2005 | 4 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K043418 (Cook Urological, Inc., 2005) has gone furthest, with 4 descendants of its own.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033778 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033778: Modification to Bard Aquaguide Ureteral Conduit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033778
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026