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510(k) Data Aggregation
K Number
K160510Device Name
MAKO 7
Manufacturer
Date Cleared
2016-06-09
(106 days)
Product Code
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
nVision Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MAKO 7 is a hysteroscope accessory, placed through the working channel of a hysteroscope to obtain samples from the fallopian tube for cytological evaluation.
Device Description
The MAKO 7 is a hysteroscope accessory intended to collect cell samples from the fallopian tube. The device is comprised of a catheter and a handle. The catheter includes a balloon, a shaft (which is made up of a stainless steel tube and a Nylon tube), a sheath (Nylon 12), and a sheath knob (Polycarbonate). The handle includes a drive wheel and an extension tube that is attached to a luer in the handle body. The extension tube attaches to a commercially available inflation device via a commercially available 3-way stopcock.
In summary, the physician inserts the MAKO 7 into the working channel of the hysteroscope until the distal tip of the catheter is positioned immediately proximal to the ostium of the fallopian tube. Then, the balloon is advanced into the fallopian tube and cells are collected on its surface.
The MAKO 7 is a sterile, single-use device. The device is terminally sterilized using ethylene oxide (EO).
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