Cleared Traditional

HydroMARK Breast Biopsy Site Marker

K212158 · Devicor Medical Products, Inc. · General & Plastic Surgery
Apr 2022
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K212158 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 21, 2022, 283 days after receiving the submission on July 12, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K212158 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2021
Decision Date April 21, 2022
Days to Decision 283 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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