VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE— 510(k) K133538
Substantially EquivalentOlympus Corporation of the Americas
FDA 510(k) clearance K133538 for VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE, Substantially Equivalent on 2014-08-07. Applicant: Olympus Corporation of the Americas.
Clearance details
- Applicant
- Olympus Corporation of the Americas
- Product code
- Code NWB
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Center Valley, PA, US
Adverse events under product code NWB
product code NWB- Malfunction
- 12,503
- Total
- 12,503
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.