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510(k) Data Aggregation
K Number
K170161Device Name
New Deantronics E Green Electrosurgical Monopolar Pencils
Manufacturer
Date Cleared
2017-03-29
(70 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
New Deantronics Taiwan, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The New Deantronics E Green™ Electrosurgical Monopolar Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current.
Device Description
The E Green™ Reusable Monopolar Cord is an electrosurgical accessory used with E Green™ Disposable Electrosurgical Pencil. Electrosurgical Pencils are intended to remove tissue and control bleeding by use of high-frequency electrical current. This product is a monopolar, electrosurgical pencil which is used for most open surgeries. The pencil can be divided in two parts, one is a gamma sterilized disposable electrosurgical pencil and another is a reusable cord which needs to be autoclaved by the user before use in a standard operating room environment. The E Green™ Reusable Monopolar Cord is used ONLY in combination with E Green™ Disposable Electrosurgical Pencil. The number of uses of the Reusable Monopolar Cord following steam sterilization is 100 times.
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