K233639
- 510(k) number
- K233639
- Device name
- SmartClip Secure Soft Tissue Marker
- Applicant
- Elucent Medical, Inc. MN · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2024-12-20
- Date received
- 2023-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233639.pdf
Official FDA record: K233639
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.