# K161277: ConvertX Nephroureteral Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Brightwater Medical
- Decided: Nov 22, 2016 after 200 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: 2 generations back to K924608 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141344: Expel Nephroureteral Drainage Stent with Twist-Loc Hub System, Expel Ureteral Drainage Stent System, Boston Scientific Corp (2014) Summary page 4.

## Indications for use
The ConvertX Nephroureteral Stent System with releasable drainage catheter is delivered percutaneously and is 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. For patients for whom external drainage is not, or no longer desirable, the releasable drainage catheter may be removed, leaving the stent to provide internal drainage from the ureteropelvic junction to the bladder.

Source page: https://510kreport.com/device/K161277
Methodology: https://510kreport.com/methodology