# K993650: Ureteral Access Sheath Set - New Models

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources
- Decided: Dec 28, 1999 after 60 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: 1 generation back to K990775 (1999). 1 ancestor in all.
11 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)
- K990775: Ureteral Access Sheath Set, Applied Medical Resources (1999) Summary page 1.
- (no number) Cook Urological’s Peel Away Introducer Sets: named in the summary without a submission number
- (no number) Nottingham One-Step Tapered Dilators, Boston Scientific Corporation: named in the summary without a submission number

## Most influential descendants
- 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
- K140441: BI-Flex Ureteral Access Sheath (2014), 1 descendant 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/K993650
Methodology: https://510kreport.com/methodology