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510(k) Data Aggregation
K Number
K180552Device Name
Modified Novy Cornual Cannulation Set
Manufacturer
Cook Incorporated
Date Cleared
2018-07-12
(133 days)
Product Code
MOV, THE
Regulation Number
884.4530Why did this record match?
Product Code :
MOV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Modified Novy Cornual Cannulation Set is intended for use through the operating channel of a hysteroscope or other uterine access device, for hysteroscopic selective catheterization and cannulation of the proximal fallopian tube(s), followed by the introduction of chromotubation or contrast medium, in the evaluation of tubal patency.
Device Description
The Modified Novy Cornual Cannulation Sets consist of an introducing catheter, an obturator, and an inner catheter with wire guide, a blue endoscopic septum cap, and two female Luer lock plugs. With this submission, Cook intends to offer two Novy Sets with curved introducing catheters. Introducing catheters are 5.0 French in size. The curved introducing catheters measuring 35 centimeters or 40 centimeters in length are manufactured with Nylon Torcon with a bonded Nonradiopaque tip. Both Novy Set are supplied sterile and intended for one-time use.
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