# K253777: Ascblue (8010)

- Pathway: 510(k) (Traditional)
- Applicant: Ascblue Corporation
- Decided: Apr 10, 2026 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: 3 generations back to K944602 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201224: Electrosurgical Generator and Accessories, Medrange (2020) Summary page 5.

## Indications for use
The Electrosurgical Generator 8010 is indicated for cutting and coagulation of tissue in general surgery procedures via monopolar and bipolar modes. It is intended for use with monopolar handpieces and dispersive electrodes, or with bipolar handpieces and footswitches.

Source page: https://510kreport.com/device/K253777
Methodology: https://510kreport.com/methodology