Iui Catheter, Model 9057

FDA 510(k) K052059 · Inntec, Inc.

Substantially Equivalent

510(k) numberK052059

Submission

Device name
Iui Catheter, Model 9057
Applicant
Inntec, Inc.
Stoughton, WI, US
Received
July 29, 2005
Decision date
November 22, 2005
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 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)DeviceApplicantDecision
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K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…MQF · Traditional Vitrolife Sweden AB07/23/2025SE
K240307VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)MQF · Traditional Shenzhen Vitavitro Biotech Co., Ltd.08/16/2024SE
K231730FemaSeed Intratubal InseminationMQF · Traditional Femasys, Inc.09/22/2023SE
K220010Daylily Single Use Sterile Embryo Transfer CatheterMQF · Traditional Shanghai Horizon Medical Technology Co., Ltd.12/16/2022SE
K200248Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft ObturatorsMQF · Traditional Allwin Medical Devices, Inc.07/01/2020SE
K192540Kitazato ET CathetersMQF · Traditional Kitazato Corporation05/01/2020SE
K190522Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra…MQF · Traditional Allwin Medical Devices, Inc.11/14/2019SE
K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…MQF · Special Cook Incorporated05/17/2019SE
K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator…MQF · Traditional Cook Incorporated10/24/2018SE

More from Cook Incorporated

510(k)DeviceDecision
K051742Oocyte Retrieval Needle Set, Models 917-IH and 917-SHMQE · Abbreviated 10/07/2005SE
K050521Embryo Transfer Catheter with Accessory Stylet, Models 9018, 9023, 9018-S, 9023-SMQF · Abbreviated 05/02/2005SE

Questions and answers

When was Iui Catheter, Model 9057 cleared by the FDA?

Iui Catheter, Model 9057 (K052059) received a 510(k) decision of Substantially Equivalent on November 22, 2005, 116 days after the submission was received.

What is the product code of K052059?

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