CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED— 510(k) K132389

Name: FDA 510(k) clearance K132389
Creator: U.S. Food and Drug Administration
Published: 2014-02-25

Substantially Equivalent

Daniel & 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. Device class: 2.

Clearance details

Applicant: Daniel & Daniel Consulting
Product code: Code OWN
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-01
Decision date: 2014-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orinda, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.