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510(k) Data Aggregation
K Number
K130489Device Name
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
Manufacturer
OPTIM, LLC.
Date Cleared
2013-04-19
(53 days)
Product Code
FEH
Regulation Number
876.4300Why did this record match?
Applicant Name (Manufacturer) :
OPTIM, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
Device Description
This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
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