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510(k) Data Aggregation
K Number
K201018Device Name
Encision AEM enTouch 2X Scissor
Manufacturer
Date Cleared
2020-07-15
(89 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Encision Inc.
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
The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.
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K Number
K140006Device Name
ENDOSHIELD BURN PROTECTION SYSTEM
Manufacturer
Date Cleared
2014-06-16
(165 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENCISION INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EndoShield Burn Protection System is an accessory for use with electrosurgical generators and is designed to safely deliver electrosurgical energy and to prevent injury caused by insulation failure and capacitive coupling. EndoShield performs acive electrode monitoring intended to control stray monopolar energy, caused by insulation failure and capacitive coupling in surgical instruments, along the instrument.
Device Description
EndoShield is a self-contained battery-powered electronic module (about the size of a cell phone) with integral instrument and HF power cords:
• Module plugs directly into return-electrode receptacle of ESU
- Integral cords connect module to
- AEM laparoscopic instrument
- Foot-control power output receptacle of ESU
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