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510(k) Data Aggregation
K Number
K140213Device Name
DISPOSABLE ENDOSCOPIC CANNULA
Manufacturer
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD
Date Cleared
2015-03-25
(421 days)
Product Code
HGH
Regulation Number
884.5070Why did this record match?
Applicant Name (Manufacturer) :
DONGGUAN MICROVIEW MEDICAL TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endoscopic Cannula is indicated for rapid transcervical aspiration of the first trimester of pregnancy. It has an additional feature of visualization.
Device Description
The Disposable Endoscopic Cannula is a sterile, single patient use device composed of transparent cover, suction orifice, dual-function cannula, handle, suction port, connection port, and data cable. The patient contacting components of this device are transparent cover, suction orifice and dual function cannula that are manufactured with polycarbonate.
The transparent cover contains a LED light source and CMOS camera at the distal end for visualization of the cervical canal and uterine cavity. This device has two channels, one for transcervical aspiration of the uterine cavity and the other for transmitting the image signal through a cable connected to the Endoscopic Workstation. The images captured by the camera are transmitted to the endoscopic workstation through the cable for display. When the embryo tissues are located, the operator sucks out the embryo tissues through the suction orifice connected to a vacuum source.
The Disposable Endoscopic Cannula is provided with five sizes based on outer cannula diameter: 5mm (RL1205 model), 6mm (RL1206 model), 7mm (RL1207 model), 8mm (RL1208 model), and 9mm (RL1209 model) (outer diameter). All models have a length of 170mm.
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