K240248
- 510(k) number
- K240248
- Device name
- Volnewmer
- Applicant
- Classys, Inc. KR
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2024-04-29
- Date received
- 2024-01-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240248.pdf
Official FDA record: K240248
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.