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510(k) Data Aggregation
K Number
K203165Device Name
Disposable Ureteral Access Sheath
Manufacturer
Suzhou Beyo Medical Technology Co., Ltd.
Date Cleared
2021-04-30
(189 days)
Product Code
FED
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Suzhou Beyo Medical Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ureteral Access Sheath is intended to use in urologic endoscopic procedures to facilitate the passage of endoscopes.
Device Description
The Disposable Ureteral Access Sheath is one single use device, which is provided after EO sterilization. The shelf life of Disposable Ureteral Access Sheath is 3(three) years. The Disposable Ureteral Access Sheath consists of two major components: sheath assembly and dilator assembly. Sheath assembly consists of sheath hub, the dilator assembly consists of dilator, dilator hub and dilator clip. And there is a hydrophilic coating on the surface of the sheath and dilator. The Disposable Ureteral Access Sheath is designed to provide the physician with reliable access to the urinary tract, the ability to inject fluids, and act as a conduit for device changes. Like all ureteral access sheath sets, Beyo's Disposable Ureteral Access Sheath also protects the ureter during device exchanges, thus helping reduce tissue trauma. Both the dilator and sheath are radiopaque and have a lubricous hydrophilic coating. To guide the access sheath into the body orifice, the dilator is advanced over up to a 0.038" guidewire. The device can be visualized under X-ray(fluoroscopy) during placement to confirm location. The device can accept other urological instruments with OD's compatible with the sheath's OD of 10,12 and 14 Fr. The device has two assemblies, sheath assembly and dilator assembly, the two assemblies are combined through dilator clip, the dilator can insert and withdrawn easily from sheath, The dilator assembly can be fixed on the sheath assembly.
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