Cleared Traditional

COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES

K081768 · Cook Incorporated · Obstetrics & Gynecology
Dec 2008
Decision
186d
Days
Class 2
Risk

About This 510(k) Submission

K081768 is an FDA 510(k) clearance for the COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES, a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II — Special Controls, product code NAJ), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on December 23, 2008, 186 days after receiving the submission on June 20, 2008. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 870.3300.

Submission Details

510(k) Number K081768 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 2008
Decision Date December 23, 2008
Days to Decision 186 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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