TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE)— 510(k) K050091

Name: FDA 510(k) clearance K050091
Creator: U.S. Food and Drug Administration
Published: 2005-03-16

Substantially Equivalent

Direx Systems Corp.

FDA 510(k) clearance K050091 for TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE), Substantially Equivalent on 2005-03-16. Applicant: Direx Systems Corp.. Device class: 2.

Clearance details

Applicant: Direx Systems Corp.
Product code: Code LNS
Device class: Class 2
Regulation: 21 CFR 876.5990
Advisory panel: Gastroenterology, Urology
Date received: 2005-01-14
Decision date: 2005-03-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

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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.