Cleared Special

Towako Transmyometrial Embryo Transfer Set (K173431) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173431 · William A. Cook Australia Pty. , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
197d
Days
Class 2
Risk

K173431 is an FDA 510(k) clearance for the Towako Transmyometrial Embryo Transfer Set. Classified as Catheter, Assisted Reproduction (product code MQF), Class II - Special Controls.

Submitted by William A. Cook Australia Pty. , Ltd. (Eight Mile Plains, AU). The FDA issued a Cleared decision on May 18, 2018 after a review of 197 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6110 - the FDA obstetrics and gynecology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all William A. Cook Australia Pty. , Ltd. devices

Submission Details

510(k) Number K173431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 160d · This submission: 197d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQF Catheter, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - MQF Catheter, Assisted Reproduction

All 15
Devices cleared under the same product code (MQF) and FDA review panel - the closest regulatory comparables to K173431.
Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter)
K190522 · Allwin Medical Devices, Inc. · Nov 2019
Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip)
K191015 · Cook Incorporated · May 2019
Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter
K180302 · Cook Incorporated · Oct 2018
Pivet and Soft-Pass Embryo Transfer Catheter Sets
K173103 · Cook Incorporated · Apr 2018
Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
K173686 · Cook Incorporated · Apr 2018
Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter
K172051 · Cook Incorporated · Jan 2018