# K122649: Navigator HD Ureteral Access Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 12, 2012 after 104 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 K022135 (2002). 2 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022135: Ureteral Access Sheath Set (Uass), Boston Scientific Corp (2002) Summary page 1.
- K030956: Navigator Ureteral Access Sheath Set, Boston Scientific Corp (2003) Summary page 1.

## Most influential descendants
- K140323: Navigator HD Ureteral Access Sheath Sets (2014), 21 descendants of its own
- K151084: Well Lead Ureteral Access Sheath (2016), 19 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K230748: Disposable Ureteral Access Sheath (2023), 5 descendants of its own
- K203165: Disposable Ureteral Access Sheath (2021), 4 descendants of its own

## Indications for use
The UASS is indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Source page: https://510kreport.com/device/K122649
Methodology: https://510kreport.com/methodology