Cleared Traditional

HydroMARK Plus Breast Biopsy Site Marker

K221961 · Devicor Medical Products, Inc. · General & Plastic Surgery
Jul 2023
Decision
373d
Days
Class 2
Risk

About This 510(k) Submission

K221961 is an FDA 510(k) clearance for the HydroMARK Plus 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 July 13, 2023, 373 days after receiving the submission on July 5, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K221961 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date July 13, 2023
Days to Decision 373 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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