HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)— 510(k) K240527

Substantially Equivalent

Devicor Medical Products, Inc.

FDA 510(k) clearance K240527 for HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6), Substantially Equivalent on 2024-07-10. Applicant: Devicor Medical Products, Inc..

Clearance details

Applicant: Devicor Medical Products, Inc.
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2024-02-23
Decision date: 2024-07-10
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.