Cleared Traditional

MammoSTAR Biopsy Site Identifier

K251748 · Carbon Medical Technologies, Inc. · General & Plastic Surgery
Jul 2025
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K251748 is an FDA 510(k) clearance for the MammoSTAR Biopsy Site Identifier, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Carbon Medical Technologies, Inc. (St, Paul, US). The FDA issued a Cleared decision on July 23, 2025, 47 days after receiving the submission on June 6, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K251748 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2025
Decision Date July 23, 2025
Days to Decision 47 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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