# K982974: DD Ureteral Stent, Integral Stent

- Pathway: 510(k) (Traditional)
- Applicant: Rusch Intl.
- Decided: Jul 2, 1999 after 311 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) Microvasive Boston Scientific Corporation, Mardis Stent Set with guidewire: named in the summary without a submission number
- (no number) Surgitek, Cabot Medical Corporation, available with and without guidewire: named in the summary without a submission number
- (no number) Mentor filiform ureteral double pigtail silicone stent: named in the summary without a submission number
- (no number) Cook Double Pigtail Standard and AQ Stent Sets: named in the summary without a submission number
- (no number) American Catheter Amcath Uroglide Stent: named in the summary without a submission number
- (no number) Microvasive Hydro-Plus Coated Marquis-stent: named in the summary without a submission number

## Most influential descendants
- K033210: Bioteq Double Pigtail Ureteral Stent Set (2004), 3 descendants of its own
- K162104: C-Flex Ureteral Stent Set (2017), 1 descendant of its own
- K180053: Sof-Flex Ureteral Stent Set (2018), 0 descendants of its own
- K063742: Resonance Metallic Ureteral Stent (2007), 0 descendants of its own

## Indications for use
Risch ureter stents are intended for use in temporary internal drainage from the kidney to the bladder or other external collecting location.

Source page: https://510kreport.com/device/K982974
Methodology: https://510kreport.com/methodology