Cleared Traditional

CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321

K100663 · Boston Scientific Corporation · Obstetrics & Gynecology
Apr 2010
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K100663 is an FDA 510(k) clearance for the CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321, a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II — Special Controls, product code NAJ), submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on April 16, 2010, 39 days after receiving the submission on March 8, 2010. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K100663 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 2010
Decision Date April 16, 2010
Days to Decision 39 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3300

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