# K030642: Deflecting Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: May 23, 2003 after 84 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
Longest line of descent: 2 generations back to K990775 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993650: Ureteral Access Sheath Set - New Models, Applied Medical Resources (1999) Summary page 1.
- K990775: Ureteral Access Sheath Set, Applied Medical Resources (1999) Summary page 1.

## Most influential descendants
- K072521: Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath (2007), 0 descendants of its own

## Indications for use
The Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.

Source page: https://510kreport.com/device/K030642
Methodology: https://510kreport.com/methodology