K243157
- 510(k) number
- K243157
- Device name
- AtriCure cryoICE BOX (ACM)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- GXH — Device, Surgical, Cryogenic
- Decision date
- 2024-10-29
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.2 MB · U.S. public domain
Also available from FDA: K243157.pdf
Official FDA record: K243157
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.