Cleared Traditional

SmartClip Soft Tissue Marker

K180640 · Elucent Medical, Inc. · General & Plastic Surgery
Jun 2018
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K180640 is an FDA 510(k) clearance for the SmartClip Soft Tissue Marker, a Marker, Radiographic, Implantable (Class II — Special Controls, product code NEU), submitted by Elucent Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on June 4, 2018, 84 days after receiving the submission on March 12, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.

Submission Details

510(k) Number K180640 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2018
Decision Date June 04, 2018
Days to Decision 84 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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