# K030956: Navigator Ureteral Access Sheath Set

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: May 23, 2003 after 57 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.
33 later devices descend from it; 3 cite it directly.
0 of 34 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 its predicate without a number.
- (no number) Ureteral Access Sheath Set: named in the summary without a submission number

## Most influential descendants
- K122649: Navigator HD Ureteral Access Sheath Set (2012), 24 descendants of its own
- 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

## Indications for use
Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract via antegrade and/or retrograde access.

Source page: https://510kreport.com/device/K030956
Methodology: https://510kreport.com/methodology