Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240
510(k) K980366
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980366 | Date27 Feb 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Aaron 1200 High Frequency Electrosurgical Generator is a device used for low powered electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is intended for the removal and destruction of human tissue and the coagulation of bleeders.
This device is supplied as a reusable generator and is not specified as MRI safe. It is authorized under FDA 510K clearance with product code GEI and was determined to be substantially equivalent in 1998. The device is available in models A1200 and A1200/240.
Other devices from Aaron Medical Industries
Questions
AI-generated answers, 6 Oct 2026
What is the Aaron 1200 High Frequency Electrosurgical Generator used for?
The Aaron 1200 is a reusable generator designed for low powered electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is intended for the removal and destruction of human tissue and the coagulation of bleeders during surgical procedures.
How is the Aaron 1200 supplied and what models are available?
The Aaron 1200 is supplied as a reusable generator and is available in two models: A1200 and A1200/240. These models offer different power options to accommodate various surgical requirements and preferences.
Is the Aaron 1200 MRI safe and what is its regulatory status?
The Aaron 1200 is not specified as MRI safe. It is authorized under FDA 510K clearance with product code GEI and was determined to be substantially equivalent in 1998, making it suitable for use in clinical settings where electrosurgical procedures are performed.
What procedures can be performed using the Aaron 1200 Electrosurgical Generator?
The Aaron 1200 can be used for various electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is specifically designed for the removal and destruction of human tissue and the coagulation of bleeders during surgical interventions.