# K190659: Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip

- Pathway: 510(k) (Traditional)
- Applicant: Allwin Medical Devices, Inc.
- Decided: Dec 2, 2019 after 263 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ALLWIN Ureteral stents are intended to temporarily facilitate drainage of urine from kidney to bladder by trained physician. The recommended target population is adults and pediatrics. The indwelling time should not exceed thirty (30) days.

Source page: https://510kreport.com/device/K190659
Methodology: https://510kreport.com/methodology