JFil Ureteral Stents, JFil Ureteral Stents ECO KIT— 510(k) K212868

Name: FDA 510(k) clearance K212868
Creator: U.S. Food and Drug Administration
Published: 2022-01-26

Substantially Equivalent

Rocamed Sam

FDA 510(k) clearance K212868 for JFil Ureteral Stents, JFil Ureteral Stents ECO KIT, Substantially Equivalent on 2022-01-26. Applicant: Rocamed Sam. Device class: 2.

Clearance details

Applicant: Rocamed Sam
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-09
Decision date: 2022-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monaco, MC

Download summary PDF View on FDA.gov ↗

Recent devices under product code FAD

view all

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

Adverse events under product code FAD

product code FAD

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.