Cleared Special

SAGE Vitrification Kit and SAGE Vitrification Warming Kit

K170560 · CooperSurgical, Inc. · Obstetrics & Gynecology
Apr 2017
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K170560 is an FDA 510(k) clearance for the SAGE Vitrification Kit and SAGE Vitrification Warming Kit, a Media, Reproductive (Class II — Special Controls, product code MQL), submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on April 4, 2017, 36 days after receiving the submission on February 27, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6180.

Submission Details

510(k) Number K170560 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 2017
Decision Date April 04, 2017
Days to Decision 36 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQL — Media, Reproductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6180

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