Search Results
Found 1 results
510(k) Data Aggregation
K Number
K051831Device Name
GEMINI SURGICAL CONTROL & DISPLAY SYSTEM
Manufacturer
APPLIED SURGICAL, LLC
Date Cleared
2005-09-07
(63 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
APPLIED SURGICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Gemini Surgical Control & Display System is indicated for use in any surgical procedure where single or multiple electrosurgical (unipolar, harmonic scalpel, etc.) devices that with a foot control are used. The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices.
The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.
The system is intended for use in hospitals or outpatient clinics.
Device Description
The Gemini Surgical Control & Display System integrates the electrosurgical devices into a central system that uses a single Master Foot Control to activate the devices. The SurgiClear smoke evacuation activation unit is indicated for use during laparoscopic cases to automatically remove the smoke/steam/debris resulting from the use of electrosurgical instruments.
Ask a Question
Page 1 of 1