Cleared Special

HydroMARK Breast Biopsy Site Marker

K210752 · Devicor Medical Products, Inc. · General & Plastic Surgery
Apr 2021
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K210752 is an FDA 510(k) clearance for the HydroMARK Breast Biopsy Site Marker, 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 April 14, 2021, 30 days after receiving the submission on March 15, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K210752 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2021
Decision Date April 14, 2021
Days to Decision 30 days
Submission Type Special
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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