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510(k) Data Aggregation
K Number
K090792Device Name
MITAKA UNIARM
Manufacturer
Date Cleared
2009-07-06
(104 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MITAKA KOHKI CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The UniARM is for use in holding medical devices such as endoscopes and retractors in surgery.
Device Description
the Mitaka UniARM-device is for use in holding medical devices in surgery such as neuro endoscopes, general endoscopes, and hand held instruments. It is a balanced device using pneumatic brakes that can be released from a single switch near the endoscope or hand held instrument. Often referred to as a third arm it provides a stable platform to hold an endoscope or hand held instrument allowing the surgeon the use of his two arms. The system can be released by the push of one button and fixes with the release of that button. A second button is depressed by the palm as a safety device.
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