MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter

Q: What is the product code of K143669?

The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.

FDA 510(k) K143669 · Medgyn Products, Inc.

Substantially Equivalent

510(k) numberK143669

Submission

Device name: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter
Applicant: Medgyn Products, Inc.
Addison, IL, US
Received: December 24, 2014
Decision date: November 23, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MQF – Catheter, Assisted Reproduction
Device class: Class II (moderate risk)
Regulation: 21 CFR 884.6110
Specialty: Obstetrics/Gynecology

Other 510(k)s with product code MQF

510(k)	Device	Applicant	Decision
K253354	Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…MQF · Traditional	Guangzhou Hehong Biotech Co., Ltd.	02/12/2026SE
K243373	Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional	Vitrolife Sweden AB	07/23/2025SE
K240307	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional	Shenzhen Vitavitro Biotech Co., Ltd.	08/16/2024SE
K231730	FemaSeed Intratubal InseminationMQF · Traditional	Femasys, Inc.	09/22/2023SE
K220010	Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional	Shanghai Horizon Medical Technology Co., Ltd.	12/16/2022SE
K200248	Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional	Allwin Medical Devices, Inc.	07/01/2020SE
K192540	Kitazato ET CathetersMQF · Traditional	Kitazato Corporation	05/01/2020SE
K190522	Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional	Allwin Medical Devices, Inc.	11/14/2019SE
K191015	Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special	Cook Incorporated	05/17/2019SE
K180302	Guardia Access Malleable Obturator, Guardia Obturator, Soft-Pass Obturator…MQF · Traditional	Cook Incorporated	10/24/2018SE

More from Cook Incorporated

510(k)	Device	Decision
K122973	AL-106, AL-106SA and AL-106B Medgyn Digital Video ColposcopeHEX · Traditional	06/12/2013SE
K945179	Bottle Collection SetHGF · Traditional	01/26/1995SE
K880196	LaminariaHDY · Traditional	05/06/1988SE
K880195	GynescopeHEX · Traditional	03/14/1988SE

Questions and answers

When was MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter cleared by the FDA?

MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter (K143669) received a 510(k) decision of Substantially Equivalent on November 23, 2015, 334 days after the submission was received.

What is the product code of K143669?

The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.