# K060673: Pediatric Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Resources Corp.
- Decided: Mar 29, 2006 after 15 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cook Sot-Flex Pediatric Double Pigtail Stent: named in the summary without a submission number
- (no number) Applied Medical Ureteral Stent: named in the summary without a submission number

## Most influential descendants
- K170010: Salle Intraoperative Pyeloplasty Stent Set (2017), 0 descendants of its own

## 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 Pediatric 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, with carcinoma of abdominal organs, retroperitoneal fibrosis, or in association with extracorporeal shockwave lithotripsy, (ESWL) in patients 2 years of age and older. 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/K060673
Methodology: https://510kreport.com/methodology