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510(k) Data Aggregation
K Number
K020891Device Name
NAKAO SNARE II AND NAKAO SNARE III
Manufacturer
GRANIT MEDICAL INNOVATIONS
Date Cleared
2002-06-17
(90 days)
Product Code
FDI
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
GRANIT MEDICAL INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.
Device Description
This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.
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