# K173734: RocaJJ Soft Stents

- Pathway: 510(k) (Traditional)
- Applicant: Promepla Sam
- Decided: Mar 12, 2018 after 96 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: 5 generations back to K903345 (1991). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043193: Bard Inlayoptima Ureteral Stent with Suture, C.R. Bard, Inc. (2004) Summary page 4.
- K151051: Universa Soft Ureteral Stents and Stent Sets, Cook Incorporated (2016) Summary page 4.

## Most influential descendants
- K212868: JFil Ureteral Stents, JFil Ureteral Stents ECO KIT (2022), 0 descendants of its own

## Indications for use
The RocaJJ Soft Stents are used for temporary internal drainage from the ureteropelvic junction to the bladder. Ureteral stents have been used to relieve obstruction in a variety of benign, malignant, and post-traumatic conditions. The stents may be placed using endoscopic techniques. The stents are not intended as a permanent indwelling devices, it is recommended that: - The indwelling time not exceed 6 days when the device is used with the removal string; - The indwelling time not exceed 365 days when the device is used without the removal string. Target population: adults only (at least 22 years old)

Source page: https://510kreport.com/device/K173734
Methodology: https://510kreport.com/methodology