510(k) Report

510(k) · Cleared

Recalled · 2007

Cook Pediatric Flexor Ureteral Access Shealth

K043418510(k) TraditionalCleared Mar 31, 2005108-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Urological, Inc. · FED Endoscopic Access Overtube, Gastroenterology-Urology

Cleared on Mar 31, 2005 as substantially equivalent to K961904 (Cook Urological, Inc., 1996) and 5 other predicates after a 108-day review. Its family tree reaches back 2 generations to 1999. 4 later devices descend from it. It has been recalled once.

Decided
Mar 31, 2005
Review
108 days
Class
Class II
Product code
FED
Recalls
1
Predicates
6

Its longest line of descent runs back 2 generations to K990775 (1999). 6 ancestors in all, the oldest K961904 (1996). 4 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 3 other ancestors1996: 1 other ancestor2007: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant clearedK990775 · Ureteral Access Sheath Set · Applied Medical Resources · 1999K993650 · Ureteral Access Sheath Set - New Models · Applied Medical Resources · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants K993650 · Ureteral Access Sheath Set - New Models · Applied Medical Resources · 1999K990775 · Ureteral Access Sheath Set · Applied Medical Resources · 19990
  1. Root · 2 generations backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
  2. 1 generation backK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
  3. This deviceK043418 Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005
  4. Descendant · cites it directly · 2 of its ownK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
  5. Descendant · 2 generations on · 0 of its ownK250132 Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025
  6. Descendant · 2 generations on · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
  7. Descendant · cites it directly · 0 of its ownK072521 Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · Recalled

Most influential descendants

Showing 4 of 4 · See all
  • K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated · 2017 · cites it directly2descendants
  • K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
  • K182403Peel-Away IntroducerCook Incorporated · 2019 · 2 generations on0descendants
  • K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K990775Ureteral Access Sheath SetApplied Medical Resources1999—
−1K993650Ureteral Access Sheath Set - New ModelsApplied Medical Resources1999—
0 (this device)K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc.2005—
+1K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral…Cook Incorporated2017—
+2K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.2025—
+2K182403Peel-Away IntroducerCook Incorporated2019—
+1K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.20071

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200330

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201710
201910
202510
FIG. 1 — Lineage of K043418, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K961904AQ Hydrophilic Dilators
Summary page 1
…chnology to exist predicate devices in commercial distribution. Specifically, the Cook® Pediatric Flexor Ureteral Access Sheath is similar to the AQ Hydrophilic Dilator (K961 904) manufactured by Cook Urological, Incorporated, the Bard® Aqua Guide Ureteral Conduit (K030438) manufactured by C.R. Bard, Incorp…
Cook Urological, Inc.1996—
*K030438Bard Aquaguide Ureteral Conduit
Summary page 1
…c Flexor Ureteral Access Sheath is similar to the AQ Hydrophilic Dilator (K961 904) manufactured by Cook Urological, Incorporated, the Bard® Aqua Guide Ureteral Conduit (K030438) manufactured by C.R. Bard, Incorporated, the Bard® Aqua Guide Ureteral Access Sheath (K033778) manufactured by C.R. Bard, Incorp…
C.R. Bard, Inc.2003—
*K033778Modification to Bard Aquaguide Ureteral Conduit
Summary page 1
…d by Cook Urological, Incorporated, the Bard® Aqua Guide Ureteral Conduit (K030438) manufactured by C.R. Bard, Incorporated, the Bard® Aqua Guide Ureteral Access Sheath (K033778) manufactured by C.R. Bard, Incorporated, the Ureteral Access Sheath Set (K993650) manufactured by Applied Medical Resources Corp…
C.R. Bard, Inc.2003—
*K993650Ureteral Access Sheath Set - New Models
Summary page 1
…) manufactured by C.R. Bard, Incorporated, the Bard® Aqua Guide Ureteral Access Sheath (K033778) manufactured by C.R. Bard, Incorporated, the Ureteral Access Sheath Set (K993650) manufactured by Applied Medical Resources Corporation, the Ureteral Access Sheath Set (K990715) manufactured by Applied Medical…
Applied Medical Resources1999—
*K990775Ureteral Access Sheath Set
Our reading of the summary gave K990715, FDA’s number for Shimadzu Ceiling Tube Support CH-30GH (Shimadzu Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ureteral Access Sheath Set”.
Applied Medical Resources1999—
*K030956Navigator Ureteral Access Sheath Set
Summary page 1
…lied Medical Resources Corporation, the Ureteral Access Sheath Set (K990715) manufactured by Applied Medical Resources Corporation, and the Ureteral Access Sheath Set 11(K030956) manufactured by Boston Scientific Corporation (Microvasive). Device Description: The Cook® Pediatric Flexor Ureteral Access She…
Boston Scientific Corp2003—

Also cleared against K961904: 4 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated20172
K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc.20070

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 5, 2007Not classifiedZ-0377-2007OtherLack of assurance of sterility, as the packages may not have been sealed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.3 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K172217 (Cook Incorporated, 2017) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K961904.

How does its category compare?

All FED devices

FED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FED

11in 2025

2007: 12008: 12009: 42010: 32011: 12012: 42013: 22014: 42015: 22016: 52017: 12018: 42019: 52020: 42021: 32022: 12023: 32024: 62025: 112026 (partial year): 6
2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FED

120in 2025

2009: 90 days median2010: 90 days median2012: 82 days median2014: 123 days median2016: 126 days median2018: 122 days median2019: 94 days median2020: 117 days median2021: 189 days median2023: 138 days median2024: 98 days median2025: 120 days median2026 (partial year): 67 days median
2007high 189 (2021) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FED

4in 2024

2007: 12013: 32024: 4, 4 Class I
2007high 4 (2024) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · FED

115in 2025

2007: 142008: 182009: 192010: 192011: 202012: 352013: 252014: 342015: 352016: 292017: 322018: 342019: 302020: 332021: 552022: 362023: 532024: 642025: 115
2007high 115 (2025) · low 14 (2007)2025

MAUDE reports naming product code FED, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—114
20081—018
2009490019
2010390019
20111—020
2012482035
20132—325
20144123034
20152—035
20165126029
20171—032
20184122034
2019594030
20204117033
20213189055
20221—036
20233138053
20246984 (4)64
2025111200115
20266670—

What is it indicated for?

Used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Cook® Pediatric Flexor Ureteral Access Sheath is intended for Pediatric Use in patients two years of age and older.

Indications for use as stated in the FDA summary.

Also cleared against K961904

4 other devices cite the same predicate.

  • K173654Ureteral Dilator Sets, Ureteral DilatorsCook Incorporated · 2018
  • K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp. · 20171 recall
  • K990808PBN DilatorsMedical Device Technologies, Inc. · 1999
  • K981611Snap-N-Peel IntroducersCircon Corp. · 1998

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls

Recent decisions in FED

The FED category page

  • K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd. · 2026
  • K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc. · 2026
  • K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd. · 2026
  • K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation · 2026
  • K260965CVAC Aspiration SystemCalyxo, Inc. · 2026

https://510kreport.com/device/K043418 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043418: Cook Pediatric Flexor Ureteral Access Shealth.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043418

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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