# K261915: Navigator™ Flex Ureteral Access Sheath Set

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Aug 4, 2026 after 56 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: 6 generations back to K770378 (1977). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161110: ClearPetra Suction-Evacuation Sheath, Well Lead Medical Co., Ltd. (2016) Summary page 5.

## Indications for use
The Navigator™ Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction.

Source page: https://510kreport.com/device/K261915
Methodology: https://510kreport.com/methodology