# K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Jun 26, 2023 after 265 days
- Product code: NEY (System, Ablation, Microwave And 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: 12 generations back to K870028 (1987). 44 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200298: ABI Instrument, Creo Electrosurgical System, Creo Medical, Ltd. (2021) Summary page 4.

## Most influential descendants
- K242983: CROMA Electrosurgical Generator (PRD-EMR-050) (2025), 0 descendants of its own

## Indications for use
The AB1 Instrument, when used with the Creo Medical Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. The AB1 Instrument is not intended for use in cardiac procedures. The Creo Electrosurgical System is intended to provide microwave energy for coagulation (ablation) of soft tissue and is for use only with compatible Creo Medical instruments and accessories. The System is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K223138
Methodology: https://510kreport.com/methodology