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510(k) Data Aggregation
K Number
K230650Device Name
Monopolar Electrode Surgical Instrument
Manufacturer
Date Cleared
2023-10-12
(217 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
VHMED (Nantong) Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is a family of instruments which includes scissors, probes and forceps which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar Electrosurgical cutting and/or coagulation.
Device Description
The Monopolar Electrode Surgical Instrument is a kind of device used to cut, dissect, manipulate and/or cauterize various tissues during endoscopic/laparoscopic, general surgical procedures. The Monopolar Electrode Surgical Instrument is provided sterile when they're released. The device consists of a conductive jaw tip, an insulated shaft and a conductive post which allows it can be connected through an appropriate cable to an electrosurgical generator. The device is available with different handles and different tip designs.
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