K240527
- 510(k) number
- K240527
- Device name
- HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
- Applicant
- Devicor Medical Products, Inc. OH · US
- Product code
- NEU — Marker, Radiographic, Implantable
- Decision date
- 2024-07-10
- Date received
- 2024-02-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K240527.pdf
Official FDA record: K240527
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.