Cleared Special

Double Lumen Ovum Aspiration Needles

K171611 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
Dec 2017
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K171611 is an FDA 510(k) clearance for the Double Lumen Ovum Aspiration Needles, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on December 15, 2017, 197 days after receiving the submission on June 1, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K171611 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2017
Decision Date December 15, 2017
Days to Decision 197 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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