K251813
- 510(k) number
- K251813
- Device name
- CURIS II RF Generator (REF 360100-05)
- Applicant
- Sutter Medizintechnik GmbH DE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2026-02-11
- Date received
- 2025-06-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251813.pdf
Official FDA record: K251813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.