MODIFICATION TO TRIPTER X-1 COMPACT DUET— 510(k) K041582

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K041582 for MODIFICATION TO TRIPTER X-1 COMPACT DUET, Substantially Equivalent on 2004-07-07. Applicant: Direx Systems Corp..

Clearance details

Applicant: Direx Systems Corp.
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2004-06-14
Decision date: 2004-07-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick, MA, US

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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.