# K213186: NovoFlow Reinforced Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast Corp.
- Decided: Feb 16, 2022 after 140 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: 3 generations back to K881744 (1988). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180057: Vortek Ureteral Double Loop Stent, Coloplast Corp. (2018) Summary page 4.

## Indications for use
The NovoFlow Reinforced ureteral stents are intended for patients 12 years of age (40 kg) and over for drainage of the upper urinary tract over fistulas or ureteral obstacles and/or for healing of the ureter. These stents may remain implanted for up to 6 months.

Source page: https://510kreport.com/device/K213186
Methodology: https://510kreport.com/methodology