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510(k) Data Aggregation
K Number
K250657Device Name
gi2000 Electrosurgical Generator
Manufacturer
Cintron Medical Corporation
Date Cleared
2025-06-03
(90 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Cintron Medical Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.
Device Description
The gi2000 is an electrosurgical generator for use in flexible endoscopic clinical settings, employing high-frequency energies to carry out cutting and coagulation of tissue during gastrointestinal surgical procedures. This isolated output electrosurgical unit (ESU) includes all standard features commonly utilized in a broad spectrum of gastrointestinal surgical procedures, encompassing monopolar cutting, monopolar coagulation, and monopolar spray coagulation, along with bipolar coagulation.
The gi2000 consists of the high-frequency electrosurgical unit with control panel and an operating foot switch. The handpiece (electrodes) and dispersive pad (return electrode) are not included with the gi2000. Instead, device labeling lists optional pieces that have been validated with the device.
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