ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits— 510(k) K213185

Unknown

Coloplast Corp.

FDA 510(k) clearance K213185 for ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits, Unknown on 2022-06-08. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-29
Decision date: 2022-06-08
Decision: Unknown
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.