NEXTSTEP RETROGRADE— 510(k) K130192

Unknown

Arrow International, Inc.

FDA 510(k) clearance K130192 for NEXTSTEP RETROGRADE, Unknown on 2013-05-10. Applicant: Arrow International, Inc..

Clearance details

Applicant: Arrow International, Inc.
Product code: Code MSD
Advisory panel: Gastroenterology, Urology
Date received: 2013-01-25
Decision date: 2013-05-10
Decision: Unknown
Clearance type: Traditional
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MSD

product code MSD

Death: 67
Injury: 545
Malfunction: 3,661
Total: 4,273

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.