# K033210: Bioteq Double Pigtail Ureteral Stent Set

- Pathway: 510(k) (Traditional)
- Applicant: Bioteque Corp.
- Decided: Dec 30, 2004 after 454 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: 1 generation back to K982974 (1999). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K982974: DD Ureteral Stent, Integral Stent, Rusch Intl. (1999) Summary page 1.

## Most influential descendants
- 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
BIOTEQ® DOUBLE PIGTAIL URETERAL STENT SET is intended to facilitate the temporary internal drainage of urine from the kidney to the bladder via placement endoscopically by a trained physician.

Source page: https://510kreport.com/device/K033210
Methodology: https://510kreport.com/methodology