K231468
- 510(k) number
- K231468
- Device name
- SCOUT MD Surgical Guidance System
- Applicant
- Merit Medical System, Inc. UT · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2024-02-12
- Date received
- 2023-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231468.pdf
Official FDA record: K231468
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.