# K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 17, 2014 after 148 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- 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 K924608 (1994). 1 ancestor in all.
6 later devices descend from it; 6 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924608: Hydrogel Coated Percuflex (R) Drainage Catheters, Boston Scientific Corp (1994) Summary page 5.

## Most influential descendants
- K183051: Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set (2019), 0 descendants of its own
- K180216: Seidmon Antegrade AQ Stent Set (2018), 0 descendants of its own
- K180029: Malecot Nephrostomy Catheter/Stent Set (2018), 0 descendants of its own
- K171603: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set (2018), 0 descendants of its own
- K170010: Salle Intraoperative Pyeloplasty Stent Set (2017), 0 descendants of its own

## Indications for use
The Expel Nephroureteral Stents are delivered percutaneously and are intended to establish internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent, as well as providing external drainage. The Expel Ureteral Stent System is delivered percutaneously and is intended to establish drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally.

Source page: https://510kreport.com/device/K141344
Methodology: https://510kreport.com/methodology