HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)

FDA cleared the HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) from Devicor Medical Products, Inc. on Jan 23, 2026 under K253761, a traditional 510(k). The device falls under product code NEU, Marker, Radiographic, Implantable, regulated at 21 CFR 878.4300 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 25, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Devicor Medical Products, Inc. has one other decision in the tracker over the last 12 months: K260365 (Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char).