CAREFUSION GOLD TISSUE MARKER— 510(k) K141722

Clearance details

Applicant

Care Fusion

Product code

Code NEU

Device class

Class 2

Regulation

21 CFR 878.4300

Advisory panel

General, Plastic Surgery

Date received

2014-06-25

Decision date

2015-01-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

• K253761 — HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape)2026-01-23
• K253888 — MOLLI 2 System2025-12-31
• K252892 — SCOUT MD Surgical Guidance System2025-12-19
• K251989 — VizMark Preloaded Tissue Marker Device (VM-0001)2025-12-12
• K251748 — MammoSTAR Biopsy Site Identifier2025-07-23

• K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device2024-03-06
• K231888 — BD Texium Needle-Free Syringe2023-09-25
• K221319 — BD Alaris Pump Epidural Infusion Set2023-07-21
• K221327 — BD Alaris Pump Infusion Sets2023-07-21
• K223101 — BD Secondary Infusion Set2023-05-12

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 →