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510(k) Data Aggregation
K Number
K172846Device Name
Uterine Manipulator
Manufacturer
Beijing HangTian KaDi Technology R&D Institute
Date Cleared
2018-06-26
(280 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Beijing HangTian KaDi Technology R&D Institute
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HK-WQ-II are indicated for manipulation of the uterus, and injection of fluids during laparoscopic gynecologic procedures such as lapacervical hysterectomy, minilap tubal ligation, laparoscopic tubal occlusion or diagnostic laparoscopy.
The HK-ZQ-I and HK-ZQ-II are intended for use in laparoscopic procedures where it is desirable to delineate the vaginal fornices and the surgeon intends to remove or access intraperitonial tissue through the vagina by use of a colpotomy or culdotomy incision; such as laparoscopically assisted vaginal hysterectomies, total laparoscopic hysterectomies, while maintaining pneumoperitoneum by sealing the vagina while a colpotomy is performed.
Device Description
There are four versions of the subject device. HK-WQ-I and HK-WO-II have a curved central guide rod, while the HK-ZQ-I and HK-ZQ-II have a central guide rod which can be rotated (or "flexed") up or down using a dial on the handle.
Each device is a sterile, disposable, single-patient use device which consists of a manipulator shaft with an inflatable intrauterine balloon at the proximal end. The intrauterine balloon is inflated by liquid via a standard syringe injected through the check valve. The internal injection tip of the manipulator shaft is open to allow direct intrauterine introduction of medicine liquid via the injector port. The device also incorporates a vaginal sealing balloon which is inflated by liquid via a standard syringe injected through the check valve to seal the vagina and maintain pneumoperitoneum. The location of the uterus can be adjusted by the handle.
Each device version can be used with a cervical cup. During use, the open-end of the cup rests on the cervix. There are two versions of the cup- a ceramic version and a polyphenylene sulfite version. For both materials, the cup is available in four different sizes - 30mm, 35mm, 40mm and 46mm.
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K Number
K172789Device Name
Specimen Retrieval Bag
Manufacturer
Beijing HangTian KaDi Technology R&D Institute
Date Cleared
2018-02-01
(139 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Beijing HangTian KaDi Technology R&D Institute
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for use as a receptacle for the collection of tissue, organs and calculi during general and laparoscopic procedures.
Device Description
The proposed device, Specimen Retrieval Bag, is comprised of retracted bag, opening support, outer introducer shaft, outer introducer handle, inner introducer handle, string and pull loop. The device is available in a series of models. The difference between each model is the retracted bag size and volume. The device is provided sterile and single use.
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