Gemini XXP-HP— 510(k) K151298

Substantially Equivalent

Dornier Medtech America

FDA 510(k) clearance K151298 for Gemini XXP-HP, Substantially Equivalent on 2015-07-30. Applicant: Dornier Medtech America.

Clearance details

Applicant: Dornier Medtech America
Product code: Code LNS
Advisory panel: Gastroenterology, Urology
Date received: 2015-05-15
Decision date: 2015-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kennesaw, GA, 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.