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510(k) Data Aggregation
K Number
K132389Device Name
CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCAL MINIPROBES; UROFLEX B AND CYSTOLFLEX F (BOTH TRADE MARKED
Manufacturer
DANIEL & DANIEL CONSULTING
Date Cleared
2014-02-25
(208 days)
Product Code
OWN
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
**DANIEL **& **DANIEL **CONSULTING
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.
The Uroflex™ B and CystoFlex™ F Confocal Miniprobes can be used within anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.
| Confocal Miniprobes™ | Endoscope or accessory |
|----------------------|------------------------------------------------------------------------------------|
| UroFlex™ B | Cystoscope or ureteroscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
| CystoFlex™ F | Flexible Cystoscope with operating channel internal diameter ≥ 1.0mm (3 Fr) |
Device Description
The subject devices, "Uroflex""B" and "CystoFlex""F" are identical in design and materials to the bundle and their reprocessing methods.
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