# K181811: ReTrace Ureteral Access Sheath

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Sep 7, 2018 after 63 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: 2 generations back to K102485 (2010). 3 ancestors in all.
1 later device descends 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)
- K140523: RE-Trace Ureteral Access Sheath, 12/14 CH/FR, Length 35 CM, Length 45 CM, Coloplast A/S (2014) Summary page 4.
- K123675: RE-Trace Ureteral Access Sheath, 10/12 French, Length 35 and 45 CM, Ureteral Access Sheath, 12/14 CH-FR, Length 35CM, UR, Coloplast A/S (2013) Summary page 4.

## Most influential descendants
- K242173: Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K181811
Methodology: https://510kreport.com/methodology