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510(k) Data Aggregation
K Number
K123438Device Name
XENX STONE MANAGEMENT DEVICE
Manufacturer
Date Cleared
2013-01-10
(63 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
XENOLITH MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy and to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Device Description
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K Number
K113692Device Name
XENX
Manufacturer
Date Cleared
2012-08-09
(238 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
XENOLITH MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The XenX device is intended to be used endoscopically to bypass and entrap calculi from the urinary tract, to prevent retrograde migration of calculi during laser lithotripsy,and to facilitate the placement of endourological instruments during diagnostic or interventional procedures
Device Description
The XenX device combines several features in one device which facilitate an endoscopic procedure. The XenX easily tracks past ureteral kidney stone and is navigated under fluoroscopy like a urologic guidewire. Once in place, a self expandable braided structure is deployed to block the ureteral lumen and prevent stone particle migration towards the kidney. The braided structure enables a constant irrigation flow for clear uretroscopic vision during the procedure. Following stone fragmentation and if required the physician can choose to propagate a urinary stent over the device for ureteral placement.
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