Cintron Medical Corporation · Class II · Cleared Jun 3, 2025
| K-number | K250657 |
| Device name | gi2000 Electrosurgical Generator |
| Applicant | Cintron Medical Corporation |
| Product code | GEI |
| Device class | Class II |
| Decision date | Jun 3, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4400 |
The gi2000 is an electrosurgical generator designed for flexible endoscopic gastrointestinal surgical procedures. It delivers high-frequency electrical energy to perform cutting and coagulation of tissue, offering monopolar cutting, monopolar coagulation, monopolar spray coagulation, and bipolar coagulation modes.
The gi2000 and predicate devices both operate at approximately 350 kHz with a maximum power output of 220 Watts for standard modes. Key differences are in software implementation (including graphical user interface), number of control screens, and power consumption—none of which raise safety or effectiveness concerns based on performance testing.
Not stated in this summary.
The gi2000 shares the same fundamental technology, operating frequency (~350 kHz), maximum power output (220 Watts), and intended use as the predicate Gi4000. Three nonclinical performance studies—ex-vivo comparative testing, accessory compatibility testing, and in-vivo preclinical testing on a swine model—demonstrated that the subject device produces similar spot sizes, penetration depths, and surgical performance outcomes as the predicates, confirming that software and design differences do not introduce new safety or effectiveness concerns.
View the full FDA submission: accessdata.fda.gov