gi2000 Electrosurgical Generator
FDA 510(k) clearance K250657 · decided 2025-06-03
Clearance details
- K-number
- K250657
- Device name
- gi2000 Electrosurgical Generator
- Applicant
- Cintron Medical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-03-05
- Decision date
- 2025-06-03
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Westminster, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.