SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025— 510(k) K083802

Substantially Equivalent

Medi-Globe Corporation

FDA 510(k) clearance K083802 for SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025, Substantially Equivalent on 2009-03-20. Applicant: Medi-Globe Corporation.

Clearance details

Applicant: Medi-Globe Corporation
Product code: Code FCG
Advisory panel: Gastroenterology, Urology
Date received: 2008-12-22
Decision date: 2009-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FCG

product code FCG

Death: 13
Injury: 576
Malfunction: 1,966
Total: 2,555

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.