K253761
- 510(k) number
- K253761
- Device name
- HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)
- Applicant
- Devicor Medical Products, Inc. OH · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2026-01-23
- Date received
- 2025-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K253761.pdf
Official FDA record: K253761
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.