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510(k) Data Aggregation
K Number
K173495Device Name
Single Use Hot Biopsy Forceps FD-231
Manufacturer
Date Cleared
2018-11-30
(382 days)
Regulation Number
876.4300Why did this record match?
Product Code :
QEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This instrument has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.
The product is only intended for adult populations.
Device Description
Single Use Hot Biopsy Forceps FD-231 has been designed to be used with an Olympus endoscope to electrosurgically collect tissue, to electrosurgically cauterize, or to perform electrosurgical hemostasis within the tracheobronchial tree.
The Single Use Hot Biopsy Forceps FD-231consists of a handle and insertion portion. Fenestrated cups in the distal end of insertion are activated in the open and closed position by maneuvering the slider in the handle.
During operation, insertion will be inserted into endoscopes. Once the tissue is held by the cups. the tissue is subjected to high frequency electric current transmitted from plug which allows for collecting tissue. Once the tissue is touched by closed cups, the tissue is subjected to high frequency electric current transmitted from plug which allows for cauterization and hemostasis.
By means of high frequency electric current passing through the tissues between electrical plate attached on patient`s skin and the cups, heat will be produced from electricity resistance by the tissue and the heat will be utilized for collecting tissue, cauterization and hemostasis.
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