# K140523: RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Jul 24, 2014 after 142 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
Longest line of descent: 1 generation back to K102485 (2010). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102485: RE-Trace Ureteral Access Sheath, Coloplast A/S (2010) Summary page 1.

## Most influential descendants
- K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (2017), 2 descendants of its own
- K181811: ReTrace Ureteral Access Sheath (2018), 1 descendant of its own
- K250132: Ureteral Access Sheath (2025), 0 descendants of its own
- K242173: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (2024), 0 descendants of its own
- K182403: Peel-Away Introducer (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K140523
Methodology: https://510kreport.com/methodology