# K242983: CROMA Electrosurgical Generator (PRD-EMR-050)

- Pathway: 510(k) (Special)
- Applicant: Creo Medical, Ltd.
- Decided: Feb 5, 2025 after 132 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: 13 generations back to K870028 (1987). 46 ancestors in all.
No later device cites it as a predicate yet.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230328: Speedboat Flush SB1 Instrument, Creo Medical, Ltd. (2023) Summary page 5.
- K223138: AB1 Electrosurgical Instrument, Creo Electrosurgical System, Creo Medical, Ltd. (2023) Summary page 5.

## Indications for use
The CROMA Electrosurgical Generator is intended to provide Radiofrequency (RF) and microwave (MW) energy for cutting, coagulation, and ablation of soft tissue, when used in conjunction with compatible electrosurgical instruments and accessories. The Creo Medical Electrosurgical System is not intended for use in cardiac procedures. The Reusable Interface Cable is for connection only of a compatible Creo Medical Instrument (Surgical Accessory) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave (MW) energy for the cutting, coagulation and ablation of tissue via endoscopic access.

Source page: https://510kreport.com/device/K242983
Methodology: https://510kreport.com/methodology