OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE— 510(k) K063683
Substantially EquivalentOlympus Medical Systems Corporation
FDA 510(k) clearance K063683 for OLYMPUS XEU-M60A ENDOSCOPIC ULTRASOUND CENTER; XGF-UM180 ULTRASONIC GASTROVIDEOSCOPE, Substantially Equivalent on 2007-02-08. Applicant: Olympus Medical Systems Corporation.
Clearance details
- Applicant
- Olympus Medical Systems Corporation
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
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.