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510(k) Data Aggregation
K Number
K240364Device Name
RELIEEV Uterine Manipulator Injector (CUMI 5.0)
Manufacturer
LI Medical Corporation Ltd.
Date Cleared
2024-10-16
(253 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
LI Medical Corporation Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Use of the RELIEEV Uterine Manipulator Injector is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility Exams, and Salpingoplasty procedures where manipulation of the uterus is required.
Device Description
The "RELIEEV" Uterine Manipulator Injector is intended to be used during medical procedures where manipulation of the uterus or injection of fluids into the uterine lumen are needed. This device is a sterile, single use product consisting of a plastic (PVC) insertion tube that includes two lumens, one for inflation of a 10 mL intrauterine balloon (cuff) at the distal end of the insertion tube via the inflation valve using the provided 10 mL syringe and the other for injection of fluid through a distal end-port using a user-provided syringe via the Leur fitting. The device also includes a movable/removable rigid handle that allows alteration of the device insertion depth and includes a cervical stop, laser etched depth markings to aid in setting the insertion depth, and a pilot balloon to assess maintenance of cuff inflation. The device is curved to facilitate forward uterine manipulation. The device has an overall length of 36 cm and an outer diameter of the catheter component of 5.0 mm. When inflated with 10 mL of air, the balloon has a diameter of 23.0-24.9 mm.
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K Number
K240434Device Name
RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
Manufacturer
Li Medical Corporation Ltd.
Date Cleared
2024-09-25
(224 days)
Product Code
HHK
Regulation Number
884.1175Why did this record match?
Applicant Name (Manufacturer) :
Li Medical Corporation Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The "RELIEEV" Suction Curette (Flexible 3.0/ Standard 3.6) is used to remove samples of materials from the uterus and from the mucosal lining of the uterus by scraping or vacuum suction. These devices obtain tissue samples for purposes of biopsy precancer screening or they can be used for menstrual extraction.
Device Description
The "RELIEEV" Suction Curette is a sterile, disposable, single-use device used to obtain a sample from the uterine mucosal lining. It is available in two models – Flexible 3.0 and Standard 3.6 with outer diameters of 3.0 mm and 3.6 mm respectively. The device consists of a tube and piston made of polypropylene (PP) with a silicone O-ring. The subject device is packaged in medical paper grade pouch (60g).
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