# K160861: Proxis Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 31, 2016 after 2 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 K022135 (2002). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122649: Navigator HD Ureteral Access Sheath Set, Boston Scientific Corp (2012) Summary page 4.

## Most influential descendants
- K201815: Dornier MAGELLAN Ureteral Access Sheath (2020), 0 descendants of its own

## Indications for use
The Proxis™ ureteral access sheath is indicated for use in endoscopic urology procedures where ureteral dilation and ureteral access is desired for injection of fluids and insertion and removal of endoscopes and related instruments.

Source page: https://510kreport.com/device/K160861
Methodology: https://510kreport.com/methodology