Cleared Special

Towako Transmyometrial Embryo Transfer Set

K173431 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology
May 2018
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K173431 is an FDA 510(k) clearance for the Towako Transmyometrial Embryo Transfer Set, a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on May 18, 2018, 197 days after receiving the submission on November 2, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K173431 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 2017
Decision Date May 18, 2018
Days to Decision 197 days
Submission Type Special
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MQF — Catheter, Assisted Reproduction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.6110

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