Cleared Traditional

HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)

K240527 · Devicor Medical Products, Inc. · General & Plastic Surgery
Jul 2024
Decision
138d
Days
Class 2
Risk

About This 510(k) Submission

K240527 is an FDA 510(k) clearance for the HydroMARK? Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6), 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 10, 2024, 138 days after receiving the submission on February 23, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K240527 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2024
Decision Date July 10, 2024
Days to Decision 138 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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