# K201224: Electrosurgical Generator and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Medrange
- Decided: Sep 18, 2020 after 135 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 K944602 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102114: Medrange Electrosurgical Generator, Medrange Corporation (2010) Summary page 4.

## Most influential descendants
- K253777: Ascblue (8010) (2026), 0 descendants of its own

## Indications for use
The Electrosurgical Generator 8070 is indicated for monopolar or bipolar surgery to achieve cut or coagulation for the tissue. It is intended to be used with monopolar handpiece and dispersive electrode or bipolar handpiece and footswitches.

Source page: https://510kreport.com/device/K201224
Methodology: https://510kreport.com/methodology