K243042
- 510(k) number
- K243042
- Device name
- Co-Ablation System with Sterile Co-Ablation Probe
- Applicant
- Hygea Medical Technology Co., Ltd. CN
- Product code
- GEH — Unit, Cryosurgical, Accessories
- Decision date
- 2025-01-29
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243042.pdf
Official FDA record: K243042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.