# K043418: Cook Pediatric Flexor Ureteral Access Shealth

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Mar 31, 2005 after 108 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990775 (1999). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961904: AQ Hydrophilic Dilators, Cook Urological, Inc. (1996) Summary page 1.
- K030438: Bard Aquaguide Ureteral Conduit, C.R. Bard, Inc. (2003) Summary page 1.
- K033778: Modification to Bard Aquaguide Ureteral Conduit, C.R. Bard, Inc. (2003) Summary page 1.
- K993650: Ureteral Access Sheath Set - New Models, Applied Medical Resources (1999) Summary page 1.
- K990775: Ureteral Access Sheath Set, Applied Medical Resources (1999). 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”.
- K030956: Navigator Ureteral Access Sheath Set, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Jan 5, 2007 · Not classified · Z-0377-2007: Lack of assurance of sterility, as the packages may not have been sealed.

## Indications for use
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.

Source page: https://510kreport.com/device/K043418
Methodology: https://510kreport.com/methodology