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510(k) Data Aggregation
K Number
K243025Device Name
Ureteral Access Sheath
Manufacturer
SEPLOU (ZHUHAI) CO., LTD.
Date Cleared
2025-01-30
(125 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
SEPLOU (ZHUHAI) CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. It is designed to establish a conduit for the treatment of urinary stones or other urinary diseases during the endoscopic procedures.
Device Description
Ureteral Access Sheath is used to establish a conduit during endoscopic urological procedures facilitating the passage of endoscopes and other instruments into the urinary tract. The Ureteral Access Sheath provides ureteral dilation and a continuous working channel for the introduction of endoscopes and instruments during ureteral access procedures. Ureteral Access Sheath comes in two models: Tip-unbendable Ureteral Access Sheath and Tip-bendable Ureteral Access Sheath with suction. The Tip-unbendable Ureteral Access Sheath is offered in French size ranging from 10Fr to 14Fr and length 28cm to 45cm. The Tip-bendable Ureteral Access Sheath with Suction is offered in French size ranging from 10Fr to 13Fr and length 33cm to 50cm.
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