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510(k) Data Aggregation
K Number
K250585Device Name
LumenaTM Ureteral Access Sheath
Manufacturer
CatheGenix (Xiamen) Co., Ltd.
Date Cleared
2025-06-27
(120 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
CatheGenix (Xiamen) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LumenaTM Ureteral Access Sheath is indicated to establish a conduit during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract.
Device Description
The LumenaTM Ureteral Access Sheaths are designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures. The sheaths are available with both a bendable tip with a Y-shape joint on the proximal end and a straight tip with the outside diameters ranging from 11 to 15 French and lengths ranging from 35 to 45 centimeters. These devices are available in a single lumen configuration and include a sheath tube and a dilator. The bendable-tip sheath is intended to be connected to a negative pressure aspirator for the collection of stones or foreign bodies during the endoscopic procedure.
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