# K200298: ABI Instrument, Creo Electrosurgical System

- Pathway: 510(k) (Traditional)
- Applicant: Creo Medical, Ltd.
- Decided: Jan 5, 2021 after 334 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: 11 generations back to K870028 (1987). 43 ancestors in all.
2 later devices descend 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)
- K163105: Emprint Ablation System, Covidien, LLC (2016) Summary page 4.

## Most influential descendants
- K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System (2023), 1 descendant of its own
- K242983: CROMA Electrosurgical Generator (PRD-EMR-050) (2025), 0 descendants of its own

## Indications for use
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. The AB1 Instrument, when used with the Creo Electrosurgical System, is intended for use in coagulation (ablation) of soft tissue. The AB1 Instrument is not intended for use in cardiac procedures.

Source page: https://510kreport.com/device/K200298
Methodology: https://510kreport.com/methodology