# K170010: Salle Intraoperative Pyeloplasty Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Aug 28, 2017 after 237 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K060673: Pediatric Ureteral Stent, Applied Medical Resources Corp. (2006) Summary page 4.

## Indications for use
This device is intended to establish and maintain nephrostomy and internal drainage following pyeloplasty for pediatric patients. This device is intended for patients 6 months and older.

Source page: https://510kreport.com/device/K170010
Methodology: https://510kreport.com/methodology