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510(k) Data Aggregation
K Number
K172151Device Name
Hysteroscopy System
Manufacturer
Chongquin Jinshan Science & Technology (Group) Co., Ltd.
Date Cleared
2018-04-09
(266 days)
Product Code
HGH
Regulation Number
884.5070Why did this record match?
Product Code :
HGH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hysteroscopy System is indicated for rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy. It has an additional feature of visualization.
Device Description
The Hysteroscopy System is designed to visualize the uterus and to facilitate physicians in the procedure of vacuum aspiration of the uterine cavity during the first trimester of pregnancy. Components of the Hysteroscopy System include an EOsterilized single-use cannula and reusable image processing unit. The Hysteroscopy System is available in five sizes that differ in length and width. Each cannula includes an internal channel to draw vacuum or negative pressure up to 500 mmHg. The optical system, which includes a CMOS image sensor, lens, and 40 mW LED, is located at the distal end of the cannula. A lens cover shields the electronics from bodily fluids. The Hysteroscopy System has two connectors: one is an electrical/data connection and the second connection is for vacuum. The cannula is not indicated for use with any other accessories. The patient-contacting materials are medical grade stainless steel, polycarbonate, medical glue, and medical nylon.
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K Number
K161106Device Name
PANPAC DISPOSABLE VACUUM CURETTES
Manufacturer
PANPAC MEDICAL CORPORATION
Date Cleared
2017-01-13
(269 days)
Product Code
HGH
Regulation Number
884.5070Why did this record match?
Product Code :
HGH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For transcervical aspiration of the uterine cavity.
Device Description
Not Found
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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?
Product Code :
HGH
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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K Number
K093508Device Name
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
Manufacturer
WOMANCARE GLOBAL
Date Cleared
2010-03-04
(112 days)
Product Code
HGH, CAN
Regulation Number
884.5070Why did this record match?
Product Code :
HGH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For uterine aspiration/uterine evacuation in obstetric and gynecological patients. Indications for use are rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.
Device Description
The Rigid Cannulae are injection molded plastic devices approximately 190mm in length, made from a styrenic copolymer manufactured in sizes 6mm. 7mm. 8mm. 9mm. 10mm, 11mm, and 12mm (outer diameter), straight and curved.
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