K242983
- 510(k) number
- K242983
- Device name
- CROMA Electrosurgical Generator (PRD-EMR-050)
- Applicant
- Creo Medical, Ltd. GB
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-02-05
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K242983.pdf
Official FDA record: K242983
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.