K Number
K010002
Device Name
CONTOUR POLARIS URETERAL STENT
Date Cleared
2001-01-22

(20 days)

Product Code
Regulation Number
876.4620
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information

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§ 876.4620 Ureteral stent.

(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).

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