Cleared Special

Single Lumen Ovum Aspiration Needles

K171625 · Willian A. Cook Australia Pty, Ltd. · Obstetrics & Gynecology
Jan 2018
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K171625 is an FDA 510(k) clearance for the Single Lumen Ovum Aspiration Needles, a Needle, Assisted Reproduction (Class II — Special Controls, product code MQE), submitted by Willian A. Cook Australia Pty, Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on January 12, 2018, 224 days after receiving the submission on June 2, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6100.

Submission Details

510(k) Number K171625 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2017
Decision Date January 12, 2018
Days to Decision 224 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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