Dornier MAGELLAN Ureteral Access Sheath— 510(k) K201815

Substantially Equivalent

Dornier Medtech America, Inc.

FDA 510(k) clearance K201815 for Dornier MAGELLAN Ureteral Access Sheath, Substantially Equivalent on 2020-11-20. Applicant: Dornier Medtech America, Inc..

Clearance details

Applicant: Dornier Medtech America, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2020-07-01
Decision date: 2020-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.