K234151
- 510(k) number
- K234151
- Device name
- Isolator Synergy EnCapture Ablation System (EMH)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- OCL — Surgical Device, For Cutting, Coagulation, And/Or Ab
- Decision date
- 2024-08-27
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K234151.pdf
Official FDA record: K234151
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.