ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent— 510(k) K180469

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K180469 for ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent, Substantially Equivalent on 2018-11-06. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2018-02-21
Decision date: 2018-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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.