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510(k) Data Aggregation
K Number
K233700Device Name
Avicenna Roboflex
Date Cleared
2024-08-16
(273 days)
Product Code
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Elmed Elektronik ve Medikal Sanayi ve Ticaret Anonim Sirketi
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Avicenna Roboflex is indicated for endoscopic examination in the urinary tract with transurethral access and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Description
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