# K140323: Navigator HD Ureteral Access Sheath Sets

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Mar 7, 2014 after 25 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.
21 later devices descend from it; 2 cite it directly.
0 of 25 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 1.

## Most influential descendants
- 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
- K241181: Disposable Ureteral Guide Sheath (2024), 2 descendants of its own

## Indications for use
The Navigator™ HD Ureteral Access Sheath Set 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/K140323
Methodology: https://510kreport.com/methodology