Cleared Special

OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN

K141365 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Aug 2014
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K141365 is an FDA 510(k) clearance for the OTRIEVA TAPERED OVUM ASPIRATION NEEDLE SINGLE LUMEN, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, Queensland, AU). The FDA issued a Cleared decision on August 7, 2014, 76 days after receiving the submission on May 23, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K141365 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2014
Decision Date August 07, 2014
Days to Decision 76 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQE — Needle, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6100

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