Cleared Traditional

LumiMARK? Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK? Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK? Biopsy Site Marker (LM0215R (Rose shape))

K232615 · Devicor Medical Products, Inc. · General & Plastic Surgery
Jan 2024
Decision
137d
Days
Class 2
Risk

About This 510(k) Submission

K232615 is an FDA 510(k) clearance for the LumiMARK? Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK? Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK? Biopsy Site Marker (LM0215R (Rose shape)), 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 January 12, 2024, 137 days after receiving the submission on August 28, 2023. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K232615 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 2023
Decision Date January 12, 2024
Days to Decision 137 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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