EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)— 510(k) K234090
Substantially EquivalentSurgvision GmbH
FDA 510(k) clearance K234090 for EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004), Substantially Equivalent on 2024-03-20. Applicant: Surgvision GmbH.
Clearance details
- Applicant
- Surgvision GmbH
- Product code
- Code IZI
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Munich, DE
Adverse events under product code IZI
product code IZI- Death
- 9
- Malfunction
- 5,312
- Total
- 5,321
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.