Manufacturer
Creo Medical, Ltd.CROMA Electrosurgical Generator (PRD-EMR-050)
Country / Region:United Kingdom (GB)Submission type:Special
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K242983
- Device name
- CROMA Electrosurgical Generator (PRD-EMR-050)
- Company
- Creo Medical, Ltd.
- Country / Region
- United Kingdom(GB)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-09-26
- Decision date
- 2025-02-05
- Submission type
- Special
- Technology type
- RF Generator(AI inferred)
- Clinical applications
- SurgeryTissue RepairPain Management
- Primary application
- Surgery
- Classification source
- AI classified
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 Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments AB1 MicroBlate Flex and NP1 MicroBlate Fine instruments, intended for coagulation (ablation) of soft tissue. The Electrosurgical Generator provides microwave (MW) energy to compatible Creo Medical instruments HS1 SlypSeal, intended for coagulation (hemostasis and cauterization) of soft tissue. The Electrosurgical Generator provides microwave (MW) and radiofrequency (RF) energy to compatible Creo Medical Speedboat Instruments, intended for coagulation (hemostasis and cauterization) and cutting soft tissue. The Electrosurgical System is not intended for use in cardiac procedures.
Intended 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.
Device Description
The CROMA Electrosurgical Generator is an Electrosurgical unit (ESU) to be used with compatible electrosurgical instruments and accessories. The CROMA Electrosurgical Generator is a tabletop, non-network connected, mains powered ESU. It comprises two distinct energy sources for the independent generation of bipolar radiofrequency (RF) and microwave (MW) energies, intended to supply electrosurgical power for cutting, coagulation, and ablation of soft tissues, when connected to compatible instruments via the interface cable. The CROMA Electrosurgical Generator incorporates proprietary software developed by Creo Medical Ltd.
Summary parsed at:2026-06-20 17:45:26 UTC