NovoFlow Reinforced Ureteral Stent— 510(k) K213186

Unknown

Coloplast Corp.

FDA 510(k) clearance K213186 for NovoFlow Reinforced Ureteral Stent, Unknown on 2022-02-16. Applicant: Coloplast Corp..

Clearance details

Applicant: Coloplast Corp.
Product code: Code FAD
Advisory panel: Gastroenterology, Urology
Date received: 2021-09-29
Decision date: 2022-02-16
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.