DUET MAGNA— 510(k) K111947

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K111947 for DUET MAGNA, Substantially Equivalent on 2012-03-01. Applicant: Direx Systems Corp..

Clearance details

Applicant: Direx Systems Corp.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2011-07-08
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canton, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LNS

product code LNS

Death: 4
Injury: 320
Total: 324

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.