Ablation systems
CROMA Electrosurgical Generator
An electrically-powered component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.
CROMA Electrosurgical Generator models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| PRD-EMR-050 | — | Not stated | Available |
FDA clearances
- 510(k) K242983 February 2025
Procedures that use ablation systems
Frequently asked questions
What is CROMA Electrosurgical Generator used for?
An electrically-powered component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.
Who makes CROMA Electrosurgical Generator?
CROMA Electrosurgical Generator is made by Creo Medical Limited. It is listed under tumor ablation systems (microwave, rf, cryo) in our device library.
What sizes does CROMA Electrosurgical Generator come in?
The FDA device database does not list sizes for CROMA Electrosurgical Generator. Check the instructions for use or ask a Creo Medical Limited representative.
Is CROMA Electrosurgical Generator MRI safe?
The FDA device database entry for CROMA Electrosurgical Generator does not state its MRI safety status. Check the labeling before MRI.
Is CROMA Electrosurgical Generator FDA cleared?
CROMA Electrosurgical Generator is covered by FDA submission K242983.
How do I contact a Creo Medical Limited sales representative?
Creo Medical Limited has not listed representatives on LA Vascular yet. Visit the Creo Medical Limited company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.