K251108
- 510(k) number
- K251108
- Device name
- Erbe ESU Model VIO® 3n with Accessories
- Applicant
- Erbe Elektromedizin GmbH DE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-08-29
- Date received
- 2025-04-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251108.pdf
Official FDA record: K251108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.