# K102485: RE-Trace Ureteral Access Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Oct 18, 2010 after 49 days
- Product code: FED (Endoscopic Access Overtube, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 2 cite it directly.
0 of 28 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 no predicate by number.

## Most influential descendants
- K123675: RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access Sheath, 12/14 CH-FR, Length 35CM, UR (2013), 22 descendants of its own
- K151084: Well Lead Ureteral Access Sheath (2016), 19 descendants of its own
- K161110: ClearPetra Suction-Evacuation Sheath (2016), 7 descendants of its own
- K230748: Disposable Ureteral Access Sheath (2023), 5 descendants of its own
- K140523: RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM (2014), 5 descendants of its own

## Indications for use
The Re-Trace Ureteral Access Sheath is used to establish a continuous conduit during urological endoscopic procedures facilitating the passage of endoscopes and other instruments into the urinary tract.

Source page: https://510kreport.com/device/K102485
Methodology: https://510kreport.com/methodology