# K180216: Seidmon Antegrade AQ Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Cook Incorporated
- Decided: Sep 28, 2018 after 246 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 Seidmon Antegrade AQ Stent is intended for internal drainage from the ureteropelvic junction to the bladder while maintaining external access to the stent as well as providing external drainage in patients age 18 years and older when treated as adults.

Source page: https://510kreport.com/device/K180216
Methodology: https://510kreport.com/methodology