K250048
- 510(k) number
- K250048
- Device name
- NEUROMARK System (NMK00301)
- Applicant
- Neurent Medical , Ltd. IE
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2025-05-29
- Date received
- 2025-01-10
- 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: K250048.pdf
Official FDA record: K250048
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.