ReddyPort NIV Access Elbow— 510(k) K171827

Substantially Equivalent

Smd Manufacturing, LLC

FDA 510(k) clearance K171827 for ReddyPort NIV Access Elbow, Substantially Equivalent on 2018-01-19. Applicant: Smd Manufacturing, LLC.

Clearance details

Applicant: Smd Manufacturing, LLC
Product code: Code MNS
Advisory panel: Anesthesiology
Date received: 2017-06-20
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MNS

product code MNS

Death: 344
Injury: 1,160
Malfunction: 8,068
Total: 9,572

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.