Search Results
Found 1 results
510(k) Data Aggregation
K Number
K191612Device Name
Encision AEM Monopolar Laparoscopic Instruments and Accessories
Manufacturer
Date Cleared
2020-03-20
(277 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Encision Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
Device Description
Encision AEM® Monopolar Laparoscopic Instruments and Accessories incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. Encision AEM® Monopolar Laparoscopic Instruments and Accessories are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. These Encision AEM® Monopolar Laparoscopic Instruments and Accessories include reusable handles and reusable & disposable insert electrodes plus disposable sheath. Encision AEM® Monopolar Laparoscopic Instruments and Accessories, in conjunction with an AEM Monitor properly connected to the electrosurgical generator (ESU), continuously monitor and dynamically manage "stray energy" (insulation failure and capacitive coupling), which are likely out of the surgeon's field of view.
Ask a Question
Ask a specific question about this device
Page 1 of 1