Cleared Special

HydroMARK Breast Biopsy Site Marker

K161021 · Devicor Medical Products, Inc. · General & Plastic Surgery
May 2016
Decision
23d
Days
Class 2
Risk

About This 510(k) Submission

K161021 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 May 5, 2016, 23 days after receiving the submission on April 12, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K161021 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2016
Decision Date May 05, 2016
Days to Decision 23 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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