Cleared Special

TraceIT Tissue Marker - 3mL

K151998 · Augmenix, Inc. · General & Plastic Surgery
Aug 2015
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K151998 is an FDA 510(k) clearance for the TraceIT Tissue Marker - 3mL, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Augmenix, Inc. (Waltham, US). The FDA issued a Cleared decision on August 19, 2015, 30 days after receiving the submission on July 20, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K151998 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2015
Decision Date August 19, 2015
Days to Decision 30 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code NEU — Marker, Radiographic, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4300

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