Manufacturer
Cintron Medical Corporationgi2000 Electrosurgical Generator
Country / Region:United States (US)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250657
- Device name
- gi2000 Electrosurgical Generator
- Company
- Cintron Medical Corporation
- Country / Region
- United States(US)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-03-05
- Decision date
- 2025-06-03
- Submission type
- Traditional
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
The gi2000 electrosurgery unit (ESU) is intended to deliver electrosurgical outputs to perform cutting and/or coagulation, in flexible endoscopic applications.
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.
Summary parsed at:2026-06-20 17:48:16 UTC