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510(k) Data Aggregation
K Number
K192518Device Name
Reusable Monopolar Active Cord
Manufacturer
Date Cleared
2019-10-25
(42 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
US Endoscopy
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reusable Monopolar Active Cord is intended to deliver monopolar electrical current from the electrosurgical unit to electrosurgical devices or accessories requiring monopolar electrical current during endoscopic procedures.
Device Description
The Reusable Monopolar Active Cord is used during endoscopic procedures to provide monopolar energy from an Electrosurgical Generator Unit (ESU) to an Active Endoscopic accessory. The Reusable Monopolar Active Cord consists of a male ESU end and a female device end connected via an insulated cable. The male ESU end uses a bovie style connector to connect to an ESU. The female device side connects to the active connector of an Active Endoscopic accessory.
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K Number
K180731Device Name
Ultramatrix EUS Balloon
Date Cleared
2018-04-19
(30 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
(US Endoscopy)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For endoscopic ultrasound applications using the balloon method in the upper or lower gastrointestinal tract.
Device Description
Not Found
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