RocaJJ Soft Stents— 510(k) K173734

Clearance details

Applicant

Promepla Sam

Product code

Code FAD

Device class

Class 2

Regulation

21 CFR 876.4620

Advisory panel

Gastroenterology, Urology

Date received

2017-12-06

Decision date

2018-03-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Monaco, MC

• K251890 — Disposable Ureteral Stents2026-02-20
• K251469 — Endura Ureteral Stent and Stent Set2025-12-19
• K243039 — Ureteral Stents (AF-D series)2025-06-18
• K243830 — Disposable ureteral stent2025-05-14
• K250824 — Percuflex Ureteral Stent +11 more2025-04-15

• K182144 — Bi-Flex Evo2018-09-07
• K152278 — ENDOFLOW II - Irrigation, Warming and Suction System2016-02-09
• K140441 — BI-FLEX URETERAL ACCESS SHEATH2014-06-17
• K120160 — ROCAMED ROCAUS PLATINUM2012-05-14

Death

2

Injury

858

Malfunction

2,651

Other

1

Total

3,512

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →