# K990775: Ureteral Access Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Apr 21, 1999 after 43 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.
12 later devices descend from it; 3 cite it directly.
0 of 13 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 no predicate by number.

## Most influential descendants
- K993650: Ureteral Access Sheath Set - New Models (1999), 11 descendants of its own
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), 5 descendants of its own
- 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
- K120160: Rocamed Rocaus Platinum (2012), 2 descendants of its own

## Indications for use
The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.

Source page: https://510kreport.com/device/K990775
Methodology: https://510kreport.com/methodology