# K250517: Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator™ HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 28cm  (M0062502240); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator™ HD Ureteral Access Sheath Set 12/14 F x 46cm  (M0062502260); Navigator™ HD Ureteral Access Sheath Set 13/15 F x 28cm  (M006

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Mar 21, 2025 after 28 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: 3 generations back to K022135 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140323: Navigator HD Ureteral Access Sheath Sets, Boston Scientific (2014) Summary page 5.

## Indications for use
The Navigator HD Ureteral Access Sheath 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/K250517
Methodology: https://510kreport.com/methodology