CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED— 510(k) K132389
Substantially EquivalentDaniel & Daniel Consulting
FDA 510(k) clearance K132389 for CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED, Substantially Equivalent on 2014-02-25. Applicant: Daniel & Daniel Consulting.
Clearance details
- Applicant
- Daniel & Daniel Consulting
- Product code
- Code OWN
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orinda, CA, US
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
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.