DeviceClearance

K132389

Substantially Equivalent

CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED

Applicant
Daniel & Daniel Consulting
Product code
OWN
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Orinda, CA, US
Download summary PDF View on FDA.gov ↗

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.