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510(k) Data Aggregation
K Number
K974801Device Name
SINGLE CHANNEL BALLOON CANNULA
Manufacturer
CONKIN SURGICAL INSTRUMENTS LTD.
Date Cleared
1998-07-09
(199 days)
Product Code
HDP
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
CONKIN SURGICAL INSTRUMENTS LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SINGLE CHANNEL BALLOON CANNULA is to be used with the VALTCHEV UTERINE MOBILIZER, models VUM-4 or VUM-5, for mobilization of the uterus and injection of dye. It is indicated for use during those procedures requiring manipulation of the uterus such as a minilap, laparoscopic tubal occlusion or diagnostic and operative laparoscopy. It is also an efficient intrauterine injector that effectively seals the internal cervical os against the cervical backflow of fluid during its injection through the device's central lumen and as such can be used in laparoscopic tubal patency studies and, in selected patients, for such procedures as hysterosalpingography.
Device Description
SINGLE CHANNEL BALLOON CANNULA
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