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510(k) Data Aggregation
K Number
K202437Device Name
Infusion Sets for Single Use
Manufacturer
Jiangsu Suyun Medical Materials Co., Ltd.
Date Cleared
2022-03-25
(577 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Suyun Medical Materials Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The maximum use time of the infusion sets shall not exceed 24 hours. The intravenous infusion needle should be used for only single dose administration and not to be left in place for more than 2 hours.
Device Description
The proposed devices are indicated for the delivery of fluids from a container to a patient's vascular system through an infusion needle under the action of gravity. The proposed devices have 8 different configurations with 4 different filter sizes, and they are provided sterile and single use. The proposed devices include 32 models.
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K Number
K102847Device Name
DISPOSABLE ENDOMETRIAL SUCTION CURETTE
Manufacturer
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
Date Cleared
2011-04-14
(197 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Endometrial Suction Curette is indicated for obtaining endometrial tissue samples by vacuum suction for endometrial histopathology examination. The specimens obtained are then used for the following: Endometrial cancer detection, Determine response to estrogen replacement therapy, Detection of pathology resulting in: Infertility, menstrual disorders, abnormal or dysfunctional uterine bleeding, postmenopausal bleeding, endometrial dating.
Device Description
The proposed device is single-use, sterile disposable endometrial suction curette, which is intended to obtain endometrial tissue samples by vacuum suction mainly for endometrial histopathology examination and cytological examination or clinical examination in Gynaecological examination. Disposable Endometrial Suction Curette, including Type A and Type B, consists of a rod, barrel ' and sealing ring. The rod is used to generate negative pressure to draw the sample (fluid or mucous) into the barrel. The barrel is used to contain the drawn samples. The sealing ring ensures that the handle can be assembled closed with the barrel for keeping certain negative pressure.
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