Uro-N Cystoscope— 510(k) K182876
Substantially EquivalentUroviu Corporation
FDA 510(k) clearance K182876 for Uro-N Cystoscope, Substantially Equivalent on 2019-07-02. Applicant: Uroviu Corporation. Device class: 2.
Clearance details
- Applicant
- Uroviu Corporation
- Product code
- Code FAJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellevue, WA, US
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More clearances from Uroviu Corporation
view allAdverse events under product code FAJ
product code FAJ- Injury
- 533
- Malfunction
- 6,705
- Total
- 7,238
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.