# K981570: Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High Frequency Electrosurgical Generator Mod

- Pathway: 510(k) (Traditional)
- Applicant: Aaron Medical Industries
- Decided: Sep 14, 1998 after 133 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K823924 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980366: Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240, Aaron Medical Industries (1998) Summary page 1.
- K955681: Aaron 800 High Frequency Desiccator/Handpiece, Geiger Instrument Co., Inc. (1996) Summary page 1.
- K823924: Model SSE4 Electrosurgical Generator, Valleylab, Inc. (1983) Summary page 1.

## Indications for use
The Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician’s opinion are suitable candidates for the procedure. Indications for the LLETZ procedure include:: a cytological and colposcopic suspicion of CIN a transformation zone which is fully visible and fully confined to the cervix a suspicion (cytological or colposcopic) of glandular abnormalities a recurrent and troublesome cervical infection with persistent atypicality a disparity between the cytological and colposcopic diagnosis a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease

Source page: https://510kreport.com/device/K981570
Methodology: https://510kreport.com/methodology