K252056
- 510(k) number
- K252056
- Device name
- Isolator® Synergy EnCompass Clamp and Guide system (OLH, OSH, GPM100)
- Applicant
- AtriCure, Inc. OH · US
- Product code
- OCL — Surgical Device, For Cutting, Coagulation, And/Or Ab
- Decision date
- 2025-07-24
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252056.pdf
Official FDA record: K252056
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.