HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)— 510(k) K253761

Substantially Equivalent

Devicor Medical Products, Inc.

FDA 510(k) clearance K253761 for HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape), Substantially Equivalent on 2026-01-23. Applicant: Devicor Medical Products, Inc..

Clearance details

Applicant: Devicor Medical Products, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2025-11-25
Decision date: 2026-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.