Cleared Traditional

EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES

K133447 · Celonova Biosciences, Inc. · Obstetrics & Gynecology
Feb 2014
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K133447 is an FDA 510(k) clearance for the EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II — Special Controls, product code NAJ), submitted by Celonova Biosciences, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 24, 2014, 104 days after receiving the submission on November 12, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K133447 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2013
Decision Date February 24, 2014
Days to Decision 104 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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