Cleared Special

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 · Obstetrics & Gynecology
May 2019
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K191015 is an FDA 510(k) clearance for the 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), a Catheter, Assisted Reproduction (Class II — Special Controls, product code MQF), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on May 17, 2019, 30 days after receiving the submission on April 17, 2019. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6110.

Submission Details

510(k) Number K191015 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2019
Decision Date May 17, 2019
Days to Decision 30 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

Similar Devices — MQF Catheter, Assisted Reproduction

All 52
Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)
K253354 · Guangzhou Hehong Biotech Co., Ltd. · Feb 2026
Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500); EmbryoCath Embryo Transfer Catheter - Straight Malleable 180 mm (REF 17501); EmbryoCath Embryo Transfer Catheter - Straight Malleable 230 mm (REF 17502); EmbryoCath Stylet - 180 mm (REF 17510); EmbryoCath Stylet - 230 mm (REF 17511)
K243373 · Vitrolife Sweden AB · Jul 2025
VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)
K240307 · Shenzhen Vitavitro Biotech Co., Ltd. · Aug 2024
FemaSeed Intratubal Insemination
K231730 · Femasys, Inc. · Sep 2023
Daylily Single Use Sterile Embryo Transfer Catheter
K220010 · Shanghai Horizon Medical Technology Co., Ltd. · Dec 2022
Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators
K200248 · Allwin Medical Devices, Inc. · Jul 2020