Cleared Special

Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit

K152682 · Willian A. Cook Australia Pty, Ltd. · Obstetrics & Gynecology

May 2016

Decision

230d

Days

Class 2

Risk

About This 510(k) Submission

K152682 is an FDA 510(k) clearance for the Sydney IVF Cryopreservation Kit, Sydney IVF Thawing Kit, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by Willian A. Cook Australia Pty, Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on May 5, 2016, 230 days after receiving the submission on September 18, 2015. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number	K152682 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2015
Decision Date	May 05, 2016
Days to Decision	230 days
Submission Type	Special
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF