MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM— 510(k) K091257
Substantially EquivalentMedi-Globe Corporation
FDA 510(k) clearance K091257 for MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM, Substantially Equivalent on 2009-05-08. Applicant: Medi-Globe Corporation.
Clearance details
- Applicant
- Medi-Globe Corporation
- Product code
- Code FCG
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tempe, AZ, US
Adverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
Source: openFDA MAUDE database, through . 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.