# K063742: Resonance Metallic Ureteral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Cook Ireland, Ltd.
- Decided: May 8, 2007 after 141 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 K905289 (1991). 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)
- K033210: Bioteq Double Pigtail Ureteral Stent Set, Bioteque Corp. (2004) Summary page 1.
- K961446: AQ Hydrophilic Stent, Cook Urological, Inc. (1996) Summary page 1.

## Indications for use
Used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction. Intended for one-time use only.

Source page: https://510kreport.com/device/K063742
Methodology: https://510kreport.com/methodology