K243642
- 510(k) number
- K243642
- Device name
- UltraCor Twirl Breast Tissue Marker
- Applicant
- Bard Peripheral Vascular, Inc. AZ · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2025-03-24
- Date received
- 2024-11-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243642.pdf
Official FDA record: K243642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.