# K040760: Modification to Ureteral Stent

- Pathway: 510(k) (Special)
- Applicant: Applied Medical Resources Corp.
- Decided: Oct 15, 2004 after 204 days
- Product code: FAD (Stent, Ureteral)
- Device class: 2
- Regulation: 21 CFR 876.4620
- Recalls of this device: 6 (0 Class I)
- 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. The FDA summary names no predicate by number.

## Recalls of this device
- May 20, 2008 · Not classified · Z-2224-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- May 20, 2008 · Not classified · Z-2219-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- May 20, 2008 · Not classified · Z-2222-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- May 20, 2008 · Not classified · Z-2220-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- May 20, 2008 · Not classified · Z-2223-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.
- May 20, 2008 · Not classified · Z-2221-2008: The product is being recalled due to possible movement or dislodgement of the positioner marker band during use.

## Indications for use
The Applied Medical Ureteral Stent is indicated to relieve obstruction from a variety of benign and malignant conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL). The stent is also used after ureteroscopy to prevent obstruction due to edema or following accidental, or planned ureteral perforation/incision to provide drainage and a scaffold for the healing ureter. In the latter circumstance it is usually used in combination with a urethral drainage catheter (e.g. Foley Catheter). The stent may be placed using retrograde endoscopic and/or fluoroscopic techniques, or percutaneously using standard radiographic technique, or at open surgery. The stent is also indicated for use as a temporary indwelling ureteral catheter to assist in urine drainage through obstructed or strictured ureters.

Source page: https://510kreport.com/device/K040760
Methodology: https://510kreport.com/methodology