Cleared Traditional

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

K253761 · Devicor Medical Products, Inc. · General & Plastic Surgery
Jan 2026
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K253761 is an FDA 510(k) clearance for the HydroMARK? Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape), a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Devicor Medical Products, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 23, 2026, 59 days after receiving the submission on November 25, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K253761 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2025
Decision Date January 23, 2026
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code NEU — Marker, Radiographic, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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