Kitazato IUI Catheter
FDA 510(k) K162667 · Kitazato Corporation
510(k) numberK162667
Submission
- Device name
- Kitazato IUI Catheter
- Applicant
- Kitazato Corporation
Tokyo, JP - Received
- September 26, 2016
- Decision date
- May 11, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K260248 | Ultra-Fast WarmMQL · Traditional | 04/28/2026SE |
| K251305 | Ultra-Fast Vitri; Ultra-Fast WarmMQL · Traditional | 08/26/2025SE |
| K200249 | Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA]…MQL · Traditional | 10/23/2020SE |
| K193522 | iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAMQL · Traditional | 08/25/2020SE |
| K192845 | Sperm Freeze, Sperm FridgeMQL · Traditional | 08/17/2020SE |
| K192540 | Kitazato ET CathetersMQF · Traditional | 05/01/2020SE |
| K190199 | SepaSperm Washing Solution, SepaSperm SolutionMQL · Traditional | 09/26/2019SE |
| K181469 | Cryotop®US-flash and Cryotop®US-scoopMQK · Traditional | 11/09/2018SE |
| K182002 | Cumulus RemoverMQL · Traditional | 10/23/2018SE |
| K171748 | Vitrification Kit and Thawing KitMQL · Traditional | 12/14/2017SE |
Questions and answers
When was Kitazato IUI Catheter cleared by the FDA?
Kitazato IUI Catheter (K162667) received a 510(k) decision of Substantially Equivalent on May 11, 2017, 227 days after the submission was received.
What is the product code of K162667?
The FDA product code is MQF – Catheter, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6110.