510(k) K251989
K251989 is an FDA 510(k) premarket notification submitted by Breast-Med, Inc. for the device "VizMark Preloaded Tissue Marker Device (VM-0001)". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code NEU (Marker, Radiographic, Implantable), a Class II device regulated under 21 CFR 878.4300. Breast-Med, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2025
- Date Received
- June 27, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Marker, Radiographic, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4300
- Review Panel
- SU
- Submission Type